Rizatriptan

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Franck Skobieranda - One of the best experts on this subject based on the ideXlab platform.

  • Rizatriptan efficacy in ichd ii pure menstrual migraine and menstrually related migraine
    Headache, 2008
    Co-Authors: Robert Nett, Anthony Rodgers, Carolyn M. Hustad, Franck Skobieranda, Loretta Mueller, Lisa K. Mannix, Karen E. Ramsey
    Abstract:

    Objective.— To examine the efficacy of Rizatriptan for the treatment of pure menstrual migraine (PMM). Background.— In 2004, the International Headache Society proposed new research criteria for menstrual migraine (International Classification of Headache Disorders [ICHD-II]). Two subtypes were defined: PMM, in which attacks occur exclusively with menstruation, and menstrually related migraine (MRM), in which attacks may also occur at other times of the cycle. Methods.— The 2 protocols (MM1 and MM2) were identical randomized, double-blind studies. Adult patients with ICHD-II menstrual migraine were assigned to either Rizatriptan 10-mg tablet or placebo (2:1). Patients were to treat a single menstrual migraine attack of moderate or severe pain intensity. This prospectively planned substudy pooled data from patients with a diagnosis of PMM from both studies. The primary substudy endpoint was 2-hour pain relief. Efficacy data were summarized for patients with a diagnosis of MRM. Results.— Of 707 (MM1: 357, MM2: 350) patients treated in the study, 146 patients (MM1: 81, MM2: 65) had a diagnosis of PMM. The percentage of patients reporting 2-hour pain relief was significantly greater for Rizatriptan than for placebo for both PMM (73% vs 50%, P = .006) and MRM subgroups (71% vs 52%, P < .001). Most other efficacy endpoints favored Rizatriptan compared with placebo in patients with either PMM or MRM. Conclusion.— Rizatriptan 10 mg was superior to placebo for the treatment of PMM, as measured by 2-hour pain relief. Rizatriptan was also effective for the treatment of MRM and for relief of migraine-associated symptoms for both headache subtypes.

  • Efficacy and Tolerability of Coadministration of Rizatriptan and Acetaminophen vs Rizatriptan or Acetaminophen Alone for Acute Migraine Treatment
    Headache: The Journal of Head and Face Pain, 2008
    Co-Authors: Frederick G. Freitag, Anthony Rodgers, Merle L. Diamond, Seymour Diamond, Imke Janssen, Franck Skobieranda
    Abstract:

    Objective.—To evaluate the efficacy and tolerability of coadministration of Rizatriptan and acetaminophen in the acute treatment of migraine. Background.—Rizatriptan is a selective 5-HT1B/1D agonist approved for the acute treatment of migraine. Acetaminophen has been studied for acute migraine treatment. In consideration of the prominent central and peripheral mechanisms in migraine, the use of “multi-mechanism therapy” is gaining momentum in the treatment of acute migraine attacks. Study Design.—This was a randomized, double-blind, placebo-controlled trial conducted at 10 centers. Eligible patients with migraine according to International Headache Society criteria treated a single migraine attack of moderate or severe intensity within 4 h from pain onset. Patients were randomized into 1 of 4 groups (Rizatriptan 10 mg + acetaminophen 1000 mg [RA], Rizatriptan alone [R], acetaminophen alone [A], and placebo [P]). There were 3 co-primary hypotheses tested sequentially for 2-h pain relief: (1) RA would be superior to P; (2) if the first was fulfilled, RA would be superior to A; and (3) if the first 2 were fulfilled, RA would be superior to R. Results.—Of 173 patients who treated a migraine, 123 patients (71.5%) achieved pain relief within 2 h. RA (90%) was significantly better than P (46%) and A (70%), but only numerically better than R (77%) for 2-h pain relief. No significant differences were seen between the active treatment groups in adverse events. Conclusion.—Rizatriptan coadministered with acetaminophen achieved 2 of the 3 primary hypotheses,proving superior to both acetaminophen and placebo for 2-h pain relief, but failing to achieve superiority to Rizatriptan alone. RA was as well tolerated as each of the individual agents.

  • efficacy of Rizatriptan for menstrual migraine in an early intervention model a prospective subgroup analysis of the Rizatriptan tame treat a migraine early studies
    Headache, 2007
    Co-Authors: Vincent T Martin, Anthony Rodgers, Carolyn M. Hustad, Karen E. Ramsey, Larry S Seidman, Alexander Mauskop, Roger K. Cady, Franck Skobieranda
    Abstract:

    OBJECTIVE: A prospective subgroup analysis of the TAME (Treat A Migraine Early) studies examined the efficacy of Rizatriptan in patients treating a menstrual migraine attack. METHODS: Both TAME studies were randomized, placebo-controlled, and double-blind. Adults with migraine were assigned (2:1) to either Rizatriptan 10-mg tablet or placebo. Patients were instructed to treat within 1 hour of migraine onset and when the pain was mild. The primary endpoint was 2-hour pain freedom. The diagnosis of menstrual migraine was established according to the revised 2004 International Headache Society (IHS) diagnostic criteria. Data from both studies were pooled for logistic regression analyses. A test for interaction was performed to compare rates of 2-hour pain freedom between patients treating a menstrual and non-menstrual attack. RESULTS: A total of 94 patients (63 in the Rizatriptan group and 31 in the placebo group) met IHS criteria for menstrual migraine and treated a menstrual attack. The percentage of patients reporting 2-hour pain freedom was significantly greater for Rizatriptan than for placebo (63.5% vs 29.0%; odds ratio = 4.5; 95% confidence interval: 1.7, 11.9; P = .002) in those treating a menstrual attack. In those treating with Rizatriptan, the percentage of patients with 2-hour pain freedom did not statistically differ between those treating a menstrual or non-menstrual migraine attack (63.5% vs 57.5%; P = .454). CONCLUSION: Rizatriptan 10 mg was effective for the treatment of menstrual migraine in an early intervention model, as measured by 2-hour pain freedom. Rates of 2-hour pain freedom were comparable for patients treating menstrual and non-menstrual migraine attacks with Rizatriptan.

  • symptoms of cutaneous sensitivity pre treatment and post treatment results from the Rizatriptan tame studies
    Cephalalgia, 2007
    Co-Authors: Roger Cady, Anthony Rodgers, Carolyn M. Hustad, Karen E. Ramsey, Alexander Mauskop, Vincent T Martin, Franck Skobieranda
    Abstract:

    The presence of cutaneous allodynia may predict response to triptans. Identical randomized double-blind studies were conducted comparing the efficacy of Rizatriptan 10 mg or placebo administered within 1 h of headache onset, while pain was mild. The primary endpoint was freedom from pain at 2 h. Presence of symptoms suggesting cutaneous sensitivity (SCS) at baseline and at 2 h post-treatment was recorded. Before treatment, 29% of Rizatriptan patients and 22% of placebo patients reported SCS. At 2 h, the percentage of patients with SCS was significantly decreased with Rizatriptan. The presence of SCS pre-treatment was not predictive of response to Rizatriptan. Most patients with SCS at 2 h were non-responders. Early treatment with Rizatriptan significantly reduced the percentage of patients with SCS at 2 h. The presence of SCS at baseline did not predict pain-free response, but presence of SCS at 2 h correlated with lack of a 2-h pain-free response.

  • Rizatriptan for the acute treatment of ichd ii proposed menstrual migraine two prospective randomized placebo controlled double blind studies
    Cephalalgia, 2007
    Co-Authors: Lisa K. Mannix, Anthony Rodgers, Carolyn M. Hustad, Karen E. Ramsey, Loretta Mueller, Elizabeth Loder, Robert Nett, Franck Skobieranda
    Abstract:

    These are the first prospective studies to use criteria for menstrual migraine proposed in the 2004 revision of the International Classification of Headache Disorders (ICHD-II) to examine the efficacy of Rizatriptan for treatment of a menstrual attack. Two identical protocols (MM1 and MM2) were randomized, parallel, placebo-controlled, double-blind studies. Adult women with ICHD-II menstrual migraine were assigned to either Rizatriptan 10-mg tablet or placebo in a 2 : 1 ratio. Patients treated a single menstrual migraine attack of moderate or severe pain intensity. The primary end-point was 2-h pain relief and the secondary end-point was 24-h sustained pain relief. A total of 707 patients (MM1 357, MM2 350) treated a menstrual migraine attack. The percentage of patients reporting 2-h pain relief was significantly greater for Rizatriptan than for placebo (MM1 70% vs. 53%, MM2 73% vs. 50%), as was the percentage of patients reporting 24-h sustained pain relief (MM1 46% vs. 33%; MM2 46% vs. 33%). Rizatriptan...

Christopher Lines - One of the best experts on this subject based on the ideXlab platform.

  • age effects on placebo response rates in clinical trials of acute agents for migraine pooled analysis of Rizatriptan trials in adults
    Cephalalgia, 2009
    Co-Authors: Xiaoyin Fan, Anthony Rodgers, Christopher Lines, Paul Winner, Robert E Shapiro
    Abstract:

    This study examined the effect of age on placebo response rates in Rizatriptan trials in adults. Data from eight Rizatriptan adult trials involving patients treating moderate/severe migraine attacks with Rizatriptan 5 mg (N = 1819), Rizatriptan 10 mg (N = 2046) or placebo (N = 1322) were pooled for post hoc analysis. Logistic regression was used to model 2-h pain relief (reduction to mild or none) and 2-h pain freedom rates by treatment groups. Older patients had lower placebo response rates than younger patients; the estimated odds ratio (older vs. younger) for a 10-year age increase was 0.83 for pain relief [95% confidence interval (CI) 0.75, 0.93] and 0.81 for pain freedom (95% CI 0.68, 0.97). The response proportion vs. age trend was flat for Rizatriptan 5 mg and slightly increased for Rizatriptan 10 mg. The treatment-by-age interaction was significant for pain relief (P < 0.001) and pain freedom (P = 0.001), suggesting an increasing trend of treatment advantage of Rizatriptan over placebo as age increased. Age appeared to be an important predictor of placebo response rate in Rizatriptan trials, with older patients being less likely to respond to placebo and more likely to respond to Rizatriptan.

  • further evaluation of Rizatriptan in menstrual migraine retrospective analysis of long term data
    Headache, 2002
    Co-Authors: Stephen D Silberstein, Helene Massiou, Kathleen Mccarroll, Christopher Lines
    Abstract:

    Objective.—To determine the long-term efficacy of oral Rizatriptan 10-mg wafers in the treatment of menstrual migraine attacks. Methods.—Data from an extension study where patients with migraine used Rizatriptan 10 mg to treat moderate or severe migraine attacks occurring over periods of up to 6 months were included in a retrospective analysis. Patients used a diary card to record details of each migraine attack and onset of menstruation. Attacks in women were classified as menstrual or nonmenstrual according to 3 time windows relative to onset of menstruation (day 0): −3 to +3 days (7-day window), −2 to + 2 days (5-day window), and 0 to +1 days (2-day window). The analysis looked at the efficacy of Rizatriptan 10 mg by menstrual category of attack for each definition on three measures: pain relief at 2 hours (reduction of pain to mild or none), pain free at 2 hours, 24-hours sustained pain free (pain free at 2 hours with no headache recurrence and no use of additional medications from 2 to 24 hours). Results.—Ninety-five women used Rizatriptan 10 mg to treat a total of 1,839 attacks. The percentage of menstrual attacks was 30% for the –3 to +3 days definition, 23% for the −2 to +2 days definition, and 11% for the 0 to +1 days definition. Rizatriptan 10 mg was equally effective in menstrual and nonmenstrual migraine attacks regardless of the definition used. For example, using the −3 to +3 days definition, 78% of menstrual migraine attacks were relieved at 2 hours after dosing compared with 78% of nonmenstrual attacks. Pain relief rates for the other definitions were as follows: −2 to +2 days, menstrual  =  78%, nonmenstrual  =  78%; 0 to +1 days, menstrual  =  79%, and nonmenstrual  =  78%. No differences between menstrual and nonmenstrual attacks were found for the 2-hour pain free and 24-hour sustained pain free measures for any of the three definitions. Conclusion.—Rizatriptan 10-mg wafers were equally effective in the treatment of menstrual and nonmenstrual migraine attacks occurring over 6 months, regardless of the precise definition of menstrual association used and even when the outcome criteria were very stringent. These data provide further evidence that triptans are effective treatments for menstrual migraine.

  • comparison of Rizatriptan and other triptans on stringent measures of efficacy
    Neurology, 2001
    Co-Authors: J U Adelman, Kathleen Mccarroll, Michel D Ferrari, Richard B Lipton, H C Diener, K Vandormael, Christopher Lines
    Abstract:

    Objective: To compare the efficacy of oral Rizatriptan 10 mg with oral doses of sumatriptan, naratriptan, and zolmitriptan on stringent outcome measures. Methods: Retrospective analysis of data from five randomized, placebo-controlled, double-masked clinical trials in which oral Rizatriptan was directly compared with oral sumatriptan 100 mg (n = 772), 50 mg (n = 1116), 25 mg (n = 1183), naratriptan 2.5 mg (n = 413), and zolmitriptan 2.5 mg (n = 580) for the acute treatment of a moderate or severe migraine attack. Outcome measures: Percentage of patients pain-free at 2 hours, symptom-free at 2 hours (no pain, nausea, photophobia, phonophobia, vomiting, or functional disability), 24-hour sustained pain-free (no headache at 2 hours, no recurrence, and no additional antimigraine medications for 24 hours). Results: More patients taking Rizatriptan 10 mg were pain-free at 2 hours than were patients taking sumatriptan 100 mg (40% vs 33%, p = 0.019), sumatriptan 50 mg (40% vs 35%, p = 0.009), sumatriptan 25 mg (38% vs 27%, p p p = 0.041). More patients taking Rizatriptan 10 mg were symptom-free at 2 hours than were patients taking sumatriptan 100 mg (31% vs 22%, p = 0.002), sumatriptan 50 mg (33% vs 28%, p = 0.003), sumatriptan 25 mg (33% vs 24%, p p p = 0.042). More patients taking Rizatriptan 10 mg had a 24-hour sustained pain-free response than did patients taking sumatriptan 100 mg (27% vs 23%, p = 0.112), sumatriptan 50 mg (30% vs 26%, p = 0.015), sumatriptan 25 mg (27% vs 20%, p = 0.005), naratriptan 2.5 mg (29% vs 17%, p = 0.004), and zolmitriptan 2.5 mg (32% vs 24%, p = 0.013). Conclusion: Oral Rizatriptan 10 mg was more effective than oral sumatriptan, naratriptan, and zolmitriptan on stringent outcome measures of pain-free response at 2 hours, symptom-free response at 2 hours, and 24-hour sustained pain-free response.

  • meta analysis of Rizatriptan efficacy in randomized controlled clinical trials
    Cephalalgia, 2001
    Co-Authors: Elizabeth Loder, K A Mccarroll, Christopher Lines
    Abstract:

    Data from seven randomized, placebo-controlled, double-blind phase III clinical trials were analysed to further evaluate the efficacy of Rizatriptan 10 mg (n = 2068) in comparison with placebo (n = 1260) and Rizatriptan 5 mg (n = 1486) for the acute treatment of a migraine attack. Migraine was diagnosed according to International Headache Society criteria. Headache severity, associated migraine symptoms and functional disability were measured immediately before dosing and at 0.5, 1, 1.5 and 2 h. Headache recurrence (return of moderate or severe headache after an initial response) was also recorded. In addition to conventional pain relief (reduction of moderate or severe headache to mild or none) and pain free measures, the analysis looked at the elimination of associated migraine symptoms and disability in patients who had symptoms or disability at baseline. Maintenance of pain relief or pain-free status over 24 h was also analysed. At 2 h, Rizatriptan 10 mg was significantly more effective than placebo for pain relief (71% vs. 38%, P < 0.001), and for elimination of pain, nausea, photophobia, phonophobia and functional disability. The benefit was maintained over 24 h; 37% of patients on Rizatriptan 10 mg had sustained pain relief vs. 18% for placebo (P < 0.001). Rizatriptan 10 mg was also more effective than Rizatriptan 5 mg, with a significant superiority at 2 h on all measures except for elimination of nausea. The benefit was maintained over 24 h; 38% of patients on Rizatriptan 10 mg had sustained pain relief vs. 32% for Rizatriptan 5 mg (P = 0.001).

  • within patient consistency of response of Rizatriptan for treating migraine
    Neurology, 2000
    Co-Authors: C G H Dahlof, Kathleen Mccarroll, Christopher Lines, Mark S Kramer, Richard B Lipton, Michel D Ferrari
    Abstract:

    Objective: To determine the within-patient consistency of response for Rizatriptan, a 5-HT 1B/1D receptor agonist for the acute treatment of migraine. Methods: Post hoc analysis was performed on data from a randomized, double-blind, placebo-controlled clinical trial. Four hundred seventy-three patients with migraine diagnosed according to the criteria of the International Headache Society were randomly assigned to one of five sequence groups in which each patient was scheduled to treat four separate moderate or severe migraine attacks. Patients in four groups received 10 mg of Rizatriptan for three of four attacks and placebo for the remaining attack; patients in the fifth group received 10 mg of Rizatriptan for all four attacks. Headache severity, functional disability, and associated migraine symptoms were measured immediately before dosing and at regular intervals up to 4 hours after the dose. The analysis was based on efficacy at 2 hours after dosing, the last time point before escape medications were allowed. The percentages of patients who responded in a specified number of attacks after treatment with Rizatriptan were calculated. The analysis was descriptive, and no formal statistical testing was performed. Results: Of the evaluable patients who treated three migraine attacks with 10 mg of Rizatriptan (with an additional interspersed placebo-treated attack in most patients), 216 of 252 (86%) had pain relief (reduction of pain to mild or none), 122 of 252 (48%) were pain free, 211 of 250 (84%) had no nausea, 163 of 251 (65%) had no photophobia, 182 of 252 (72%) had no phonophobia, 136 of 249 (55%) had no functional disability, and 233 of 252 (92%) had no need for escape medications at 2 hours after dosing in at least two of three attacks. Conclusion: The response to 10 mg of oral Rizatriptan within individual patients was consistent over three attacks on a range of measures.–1516

Michel D Ferrari - One of the best experts on this subject based on the ideXlab platform.

  • DOI 10.1007/s10194-010-0243-y ORIGINAL A double-blind, randomized, multicenter, Italian study
    2013
    Co-Authors: Lidia Savi, Stefano Omboni, Carlo Lisotto, Lorenzo Pinessi, Giorgio Zanchin, Dario Zava, Michel D Ferrari
    Abstract:

    of frovatriptan versus Rizatriptan for the acute treatment of migrain

  • Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study versus Rizatriptan
    The Journal of Headache and Pain, 2011
    Co-Authors: Lidia Savi, Stefano Omboni, Carlo Lisotto, Giorgio Zanchin, Dario Zava, Michel D Ferrari, Lorenzo Pinessi
    Abstract:

    The objectives of this study are to assess the efficacy and safety of frovatriptan, and Rizatriptan in the subgroup of women with menstrually related migraine of a multicenter, randomized, double blind, cross-over study. Each patient received frovatriptan 2.5 mg or Rizatriptan 10 mg in a randomized sequence: after treating 3 episodes of migraine in not more than 3 months with the first treatment, the patient had to switch to the other treatment. Menstrually related migraine was defined according to the criteria listed in the Appendix of the last IHS Classification of Headache disorders. 99 out of the 125 patients included in the intention-to-treat analysis of the main study were of a female gender: 93 had regular menstrual cycles and were, thus, included in this analysis. A total of 49 attacks classified as menstrually related migraine were treated with frovatriptan and 59 with Rizatriptan. Rate of pain relief at 2 h was 58% for frovatriptan and 64% for Rizatriptan ( p  = NS), while rate of pain free at 2 h was 31 and 34% ( p  = NS), respectively. At 24 h, 67 and 81% of frovatriptan-treated, and 61 and 74% of Rizatriptan-treated patients were pain free and had pain relief, respectively ( p  = NS). Recurrence at 24 h was significantly ( p  

  • efficacy of frovatriptan in the acute treatment of menstrually related migraine analysis of a double blind randomized cross over multicenter italian comparative study versus Rizatriptan
    Journal of Headache and Pain, 2011
    Co-Authors: Lidia Savi, Stefano Omboni, Carlo Lisotto, Giorgio Zanchin, Dario Zava, Michel D Ferrari, Lorenzo Pinessi
    Abstract:

    The objectives of this study are to assess the efficacy and safety of frovatriptan, and Rizatriptan in the subgroup of women with menstrually related migraine of a multicenter, randomized, double blind, cross-over study. Each patient received frovatriptan 2.5 mg or Rizatriptan 10 mg in a randomized sequence: after treating 3 episodes of migraine in not more than 3 months with the first treatment, the patient had to switch to the other treatment. Menstrually related migraine was defined according to the criteria listed in the Appendix of the last IHS Classification of Headache disorders. 99 out of the 125 patients included in the intention-to-treat analysis of the main study were of a female gender: 93 had regular menstrual cycles and were, thus, included in this analysis. A total of 49 attacks classified as menstrually related migraine were treated with frovatriptan and 59 with Rizatriptan. Rate of pain relief at 2 h was 58% for frovatriptan and 64% for Rizatriptan (p = NS), while rate of pain free at 2 h was 31 and 34% (p = NS), respectively. At 24 h, 67 and 81% of frovatriptan-treated, and 61 and 74% of Rizatriptan-treated patients were pain free and had pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p < 0.01) lower with frovatriptan (10 vs. 32% Rizatriptan). Frovatriptan was as effective as Rizatriptan in the immediate treatment of menstrually related migraine attacks while showing a favorable sustained effect with a lower rate of migraine recurrence. These results need to be confirmed by randomized, double-blind, prospective, large clinical trials.

  • comparison of Rizatriptan and other triptans on stringent measures of efficacy
    Neurology, 2001
    Co-Authors: J U Adelman, Kathleen Mccarroll, Michel D Ferrari, Richard B Lipton, H C Diener, K Vandormael, Christopher Lines
    Abstract:

    Objective: To compare the efficacy of oral Rizatriptan 10 mg with oral doses of sumatriptan, naratriptan, and zolmitriptan on stringent outcome measures. Methods: Retrospective analysis of data from five randomized, placebo-controlled, double-masked clinical trials in which oral Rizatriptan was directly compared with oral sumatriptan 100 mg (n = 772), 50 mg (n = 1116), 25 mg (n = 1183), naratriptan 2.5 mg (n = 413), and zolmitriptan 2.5 mg (n = 580) for the acute treatment of a moderate or severe migraine attack. Outcome measures: Percentage of patients pain-free at 2 hours, symptom-free at 2 hours (no pain, nausea, photophobia, phonophobia, vomiting, or functional disability), 24-hour sustained pain-free (no headache at 2 hours, no recurrence, and no additional antimigraine medications for 24 hours). Results: More patients taking Rizatriptan 10 mg were pain-free at 2 hours than were patients taking sumatriptan 100 mg (40% vs 33%, p = 0.019), sumatriptan 50 mg (40% vs 35%, p = 0.009), sumatriptan 25 mg (38% vs 27%, p p p = 0.041). More patients taking Rizatriptan 10 mg were symptom-free at 2 hours than were patients taking sumatriptan 100 mg (31% vs 22%, p = 0.002), sumatriptan 50 mg (33% vs 28%, p = 0.003), sumatriptan 25 mg (33% vs 24%, p p p = 0.042). More patients taking Rizatriptan 10 mg had a 24-hour sustained pain-free response than did patients taking sumatriptan 100 mg (27% vs 23%, p = 0.112), sumatriptan 50 mg (30% vs 26%, p = 0.015), sumatriptan 25 mg (27% vs 20%, p = 0.005), naratriptan 2.5 mg (29% vs 17%, p = 0.004), and zolmitriptan 2.5 mg (32% vs 24%, p = 0.013). Conclusion: Oral Rizatriptan 10 mg was more effective than oral sumatriptan, naratriptan, and zolmitriptan on stringent outcome measures of pain-free response at 2 hours, symptom-free response at 2 hours, and 24-hour sustained pain-free response.

  • within patient consistency of response of Rizatriptan for treating migraine
    Neurology, 2000
    Co-Authors: C G H Dahlof, Kathleen Mccarroll, Christopher Lines, Mark S Kramer, Richard B Lipton, Michel D Ferrari
    Abstract:

    Objective: To determine the within-patient consistency of response for Rizatriptan, a 5-HT 1B/1D receptor agonist for the acute treatment of migraine. Methods: Post hoc analysis was performed on data from a randomized, double-blind, placebo-controlled clinical trial. Four hundred seventy-three patients with migraine diagnosed according to the criteria of the International Headache Society were randomly assigned to one of five sequence groups in which each patient was scheduled to treat four separate moderate or severe migraine attacks. Patients in four groups received 10 mg of Rizatriptan for three of four attacks and placebo for the remaining attack; patients in the fifth group received 10 mg of Rizatriptan for all four attacks. Headache severity, functional disability, and associated migraine symptoms were measured immediately before dosing and at regular intervals up to 4 hours after the dose. The analysis was based on efficacy at 2 hours after dosing, the last time point before escape medications were allowed. The percentages of patients who responded in a specified number of attacks after treatment with Rizatriptan were calculated. The analysis was descriptive, and no formal statistical testing was performed. Results: Of the evaluable patients who treated three migraine attacks with 10 mg of Rizatriptan (with an additional interspersed placebo-treated attack in most patients), 216 of 252 (86%) had pain relief (reduction of pain to mild or none), 122 of 252 (48%) were pain free, 211 of 250 (84%) had no nausea, 163 of 251 (65%) had no photophobia, 182 of 252 (72%) had no phonophobia, 136 of 249 (55%) had no functional disability, and 233 of 252 (92%) had no need for escape medications at 2 hours after dosing in at least two of three attacks. Conclusion: The response to 10 mg of oral Rizatriptan within individual patients was consistent over three attacks on a range of measures.–1516

Karen E. Ramsey - One of the best experts on this subject based on the ideXlab platform.

  • Rizatriptan 10 mg odt for early treatment of migraine and impact of migraine education on treatment response
    Headache, 2009
    Co-Authors: Roger Cady, Anthony Rodgers, Carolyn M. Hustad, Vincent T Martin, G Geraud, Ying Zhang, Kathryn M Connor, Karen E. Ramsey
    Abstract:

    Objective.— To examine the efficacy of Rizatriptan 10-mg orally disintegrating tablet (ODT) for treating migraines of mild intensity soon after onset, with or without patient-specific migraine education. Background.— Studies have shown Rizatriptan tablet efficacy in early migraine treatment. Methods.— In this randomized, placebo-controlled, double-blind, factorial design study, adults with a history of migraine were assigned to Rizatriptan 10-mg ODT ± patient education (personalized summary of early migraine signs and symptoms) or placebo ± patient education in a 1 : 1 : 1 : 1 ratio. Patients were instructed to treat 1 attack at the earliest time they knew that their headache was a migraine, while pain was mild. During the next 24 hours, patients assessed pain severity, associated symptoms, functional disability, use of rescue medication, and treatment satisfaction. The primary endpoint was pain freedom at 2 hours; a key secondary endpoint was 24-hour sustained pain freedom. Results.— Of 207 patients randomized to treatment, 188 (91%) treated a study migraine. Significantly more patients taking Rizatriptan reported pain freedom at 2 hours compared with placebo (66.3% vs 28.1%, P < .001). Similarly, significantly more patients taking Rizatriptan reported 24-hour sustained pain freedom (52.2% vs 17.7%, P < .001). A greater proportion of patients in the Rizatriptan + education group reported pain freedom at 2 hours compared with those in the Rizatriptan + no education group (71.7% vs 60.9%, P = .430). Few adverse events were reported. Conclusion.— Rizatriptan 10-mg ODT, when taken early, while headache pain is mild, was superior to placebo at providing pain freedom at 2 hours and 24-hour sustained pain freedom (NCT00516737).

  • Rizatriptan efficacy in ichd ii pure menstrual migraine and menstrually related migraine
    Headache, 2008
    Co-Authors: Robert Nett, Anthony Rodgers, Carolyn M. Hustad, Franck Skobieranda, Loretta Mueller, Lisa K. Mannix, Karen E. Ramsey
    Abstract:

    Objective.— To examine the efficacy of Rizatriptan for the treatment of pure menstrual migraine (PMM). Background.— In 2004, the International Headache Society proposed new research criteria for menstrual migraine (International Classification of Headache Disorders [ICHD-II]). Two subtypes were defined: PMM, in which attacks occur exclusively with menstruation, and menstrually related migraine (MRM), in which attacks may also occur at other times of the cycle. Methods.— The 2 protocols (MM1 and MM2) were identical randomized, double-blind studies. Adult patients with ICHD-II menstrual migraine were assigned to either Rizatriptan 10-mg tablet or placebo (2:1). Patients were to treat a single menstrual migraine attack of moderate or severe pain intensity. This prospectively planned substudy pooled data from patients with a diagnosis of PMM from both studies. The primary substudy endpoint was 2-hour pain relief. Efficacy data were summarized for patients with a diagnosis of MRM. Results.— Of 707 (MM1: 357, MM2: 350) patients treated in the study, 146 patients (MM1: 81, MM2: 65) had a diagnosis of PMM. The percentage of patients reporting 2-hour pain relief was significantly greater for Rizatriptan than for placebo for both PMM (73% vs 50%, P = .006) and MRM subgroups (71% vs 52%, P < .001). Most other efficacy endpoints favored Rizatriptan compared with placebo in patients with either PMM or MRM. Conclusion.— Rizatriptan 10 mg was superior to placebo for the treatment of PMM, as measured by 2-hour pain relief. Rizatriptan was also effective for the treatment of MRM and for relief of migraine-associated symptoms for both headache subtypes.

  • efficacy of Rizatriptan for menstrual migraine in an early intervention model a prospective subgroup analysis of the Rizatriptan tame treat a migraine early studies
    Headache, 2007
    Co-Authors: Vincent T Martin, Anthony Rodgers, Carolyn M. Hustad, Karen E. Ramsey, Larry S Seidman, Alexander Mauskop, Roger K. Cady, Franck Skobieranda
    Abstract:

    OBJECTIVE: A prospective subgroup analysis of the TAME (Treat A Migraine Early) studies examined the efficacy of Rizatriptan in patients treating a menstrual migraine attack. METHODS: Both TAME studies were randomized, placebo-controlled, and double-blind. Adults with migraine were assigned (2:1) to either Rizatriptan 10-mg tablet or placebo. Patients were instructed to treat within 1 hour of migraine onset and when the pain was mild. The primary endpoint was 2-hour pain freedom. The diagnosis of menstrual migraine was established according to the revised 2004 International Headache Society (IHS) diagnostic criteria. Data from both studies were pooled for logistic regression analyses. A test for interaction was performed to compare rates of 2-hour pain freedom between patients treating a menstrual and non-menstrual attack. RESULTS: A total of 94 patients (63 in the Rizatriptan group and 31 in the placebo group) met IHS criteria for menstrual migraine and treated a menstrual attack. The percentage of patients reporting 2-hour pain freedom was significantly greater for Rizatriptan than for placebo (63.5% vs 29.0%; odds ratio = 4.5; 95% confidence interval: 1.7, 11.9; P = .002) in those treating a menstrual attack. In those treating with Rizatriptan, the percentage of patients with 2-hour pain freedom did not statistically differ between those treating a menstrual or non-menstrual migraine attack (63.5% vs 57.5%; P = .454). CONCLUSION: Rizatriptan 10 mg was effective for the treatment of menstrual migraine in an early intervention model, as measured by 2-hour pain freedom. Rates of 2-hour pain freedom were comparable for patients treating menstrual and non-menstrual migraine attacks with Rizatriptan.

  • symptoms of cutaneous sensitivity pre treatment and post treatment results from the Rizatriptan tame studies
    Cephalalgia, 2007
    Co-Authors: Roger Cady, Anthony Rodgers, Carolyn M. Hustad, Karen E. Ramsey, Alexander Mauskop, Vincent T Martin, Franck Skobieranda
    Abstract:

    The presence of cutaneous allodynia may predict response to triptans. Identical randomized double-blind studies were conducted comparing the efficacy of Rizatriptan 10 mg or placebo administered within 1 h of headache onset, while pain was mild. The primary endpoint was freedom from pain at 2 h. Presence of symptoms suggesting cutaneous sensitivity (SCS) at baseline and at 2 h post-treatment was recorded. Before treatment, 29% of Rizatriptan patients and 22% of placebo patients reported SCS. At 2 h, the percentage of patients with SCS was significantly decreased with Rizatriptan. The presence of SCS pre-treatment was not predictive of response to Rizatriptan. Most patients with SCS at 2 h were non-responders. Early treatment with Rizatriptan significantly reduced the percentage of patients with SCS at 2 h. The presence of SCS at baseline did not predict pain-free response, but presence of SCS at 2 h correlated with lack of a 2-h pain-free response.

  • Rizatriptan for the acute treatment of ichd ii proposed menstrual migraine two prospective randomized placebo controlled double blind studies
    Cephalalgia, 2007
    Co-Authors: Lisa K. Mannix, Anthony Rodgers, Carolyn M. Hustad, Karen E. Ramsey, Loretta Mueller, Elizabeth Loder, Robert Nett, Franck Skobieranda
    Abstract:

    These are the first prospective studies to use criteria for menstrual migraine proposed in the 2004 revision of the International Classification of Headache Disorders (ICHD-II) to examine the efficacy of Rizatriptan for treatment of a menstrual attack. Two identical protocols (MM1 and MM2) were randomized, parallel, placebo-controlled, double-blind studies. Adult women with ICHD-II menstrual migraine were assigned to either Rizatriptan 10-mg tablet or placebo in a 2 : 1 ratio. Patients treated a single menstrual migraine attack of moderate or severe pain intensity. The primary end-point was 2-h pain relief and the secondary end-point was 24-h sustained pain relief. A total of 707 patients (MM1 357, MM2 350) treated a menstrual migraine attack. The percentage of patients reporting 2-h pain relief was significantly greater for Rizatriptan than for placebo (MM1 70% vs. 53%, MM2 73% vs. 50%), as was the percentage of patients reporting 24-h sustained pain relief (MM1 46% vs. 33%; MM2 46% vs. 33%). Rizatriptan...

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  • age effects on placebo response rates in clinical trials of acute agents for migraine pooled analysis of Rizatriptan trials in adults
    Cephalalgia, 2009
    Co-Authors: Xiaoyin Fan, Anthony Rodgers, Christopher Lines, Paul Winner, Robert E Shapiro
    Abstract:

    This study examined the effect of age on placebo response rates in Rizatriptan trials in adults. Data from eight Rizatriptan adult trials involving patients treating moderate/severe migraine attacks with Rizatriptan 5 mg (N = 1819), Rizatriptan 10 mg (N = 2046) or placebo (N = 1322) were pooled for post hoc analysis. Logistic regression was used to model 2-h pain relief (reduction to mild or none) and 2-h pain freedom rates by treatment groups. Older patients had lower placebo response rates than younger patients; the estimated odds ratio (older vs. younger) for a 10-year age increase was 0.83 for pain relief [95% confidence interval (CI) 0.75, 0.93] and 0.81 for pain freedom (95% CI 0.68, 0.97). The response proportion vs. age trend was flat for Rizatriptan 5 mg and slightly increased for Rizatriptan 10 mg. The treatment-by-age interaction was significant for pain relief (P < 0.001) and pain freedom (P = 0.001), suggesting an increasing trend of treatment advantage of Rizatriptan over placebo as age increased. Age appeared to be an important predictor of placebo response rate in Rizatriptan trials, with older patients being less likely to respond to placebo and more likely to respond to Rizatriptan.

  • Rizatriptan 10 mg odt for early treatment of migraine and impact of migraine education on treatment response
    Headache, 2009
    Co-Authors: Roger Cady, Anthony Rodgers, Carolyn M. Hustad, Vincent T Martin, G Geraud, Ying Zhang, Kathryn M Connor, Karen E. Ramsey
    Abstract:

    Objective.— To examine the efficacy of Rizatriptan 10-mg orally disintegrating tablet (ODT) for treating migraines of mild intensity soon after onset, with or without patient-specific migraine education. Background.— Studies have shown Rizatriptan tablet efficacy in early migraine treatment. Methods.— In this randomized, placebo-controlled, double-blind, factorial design study, adults with a history of migraine were assigned to Rizatriptan 10-mg ODT ± patient education (personalized summary of early migraine signs and symptoms) or placebo ± patient education in a 1 : 1 : 1 : 1 ratio. Patients were instructed to treat 1 attack at the earliest time they knew that their headache was a migraine, while pain was mild. During the next 24 hours, patients assessed pain severity, associated symptoms, functional disability, use of rescue medication, and treatment satisfaction. The primary endpoint was pain freedom at 2 hours; a key secondary endpoint was 24-hour sustained pain freedom. Results.— Of 207 patients randomized to treatment, 188 (91%) treated a study migraine. Significantly more patients taking Rizatriptan reported pain freedom at 2 hours compared with placebo (66.3% vs 28.1%, P < .001). Similarly, significantly more patients taking Rizatriptan reported 24-hour sustained pain freedom (52.2% vs 17.7%, P < .001). A greater proportion of patients in the Rizatriptan + education group reported pain freedom at 2 hours compared with those in the Rizatriptan + no education group (71.7% vs 60.9%, P = .430). Few adverse events were reported. Conclusion.— Rizatriptan 10-mg ODT, when taken early, while headache pain is mild, was superior to placebo at providing pain freedom at 2 hours and 24-hour sustained pain freedom (NCT00516737).

  • impact of recent prior opioid use on Rizatriptan efficacy a post hoc pooled analysis
    Headache, 2009
    Co-Authors: Anthony Rodgers, Marcelo E Bigal
    Abstract:

    Background.— Limited evidence suggests that, in individuals with migraine, prior use of opioids reduces responsiveness to treatment with subsequent acute migraine therapies. The evidence is more robust with regard to opioids as a risk factor for chronic migraine. Objectives.— To explore whether recent prior opioid use influenced treatment response, in a post hoc pooled analysis of Rizatriptan clinical trials. Methods.— We included Rizatriptan 10 mg and placebo data from phase 3 moderate/severe migraine studies as well as from the Rizatriptan “Treat a Migraine Early” (TAME) studies. As part of the clinical assessment, medication usage for migraine and other reasons in the 30 days prior to a screening visit and up to the time of taking study drug was captured via patient's self-report. The influence of recent prior opioid use on the endpoint of pain freedom at 2 hours was assessed via logistic regression. We further explored the influence of gender and disability on treatment response. Results.— In the moderate/severe migraine studies of 2068 individuals treated with Rizatriptan, 284 (13.7%) reported recent prior use of opioids. Of those treated with placebo (1258), 12.5% recently used opioids. In the TAME studies, the proportions were lower, 3.9% and 5.3%, respectively. The pretreatment and demographic characteristics were similar across the study groups. In the moderate/severe studies, recent prior opioid use was associated with reduced 2-hour pain freedom. Although the influence of recent prior opioid use was assessed independently of treatment, the finding was driven primarily by Rizatriptan (recent prior use vs no use: 34% vs 42% for Rizatriptan and 10% vs 10% for placebo; P = .013). In the TAME studies, recent prior opioid use was also predictive of reduced efficacy (recent prior use vs no use: 41% vs 59% for Rizatriptan and 13% vs 32% for placebo; P = .007). Conclusion.— Recent prior opioid use was associated with lower triptan response. Because of the post hoc nature of the analysis and limitations in capturing amount of opioid used, as well as to adjust for disability levels, these findings require replication in prospective studies.

  • Rizatriptan efficacy in ichd ii pure menstrual migraine and menstrually related migraine
    Headache, 2008
    Co-Authors: Robert Nett, Anthony Rodgers, Carolyn M. Hustad, Franck Skobieranda, Loretta Mueller, Lisa K. Mannix, Karen E. Ramsey
    Abstract:

    Objective.— To examine the efficacy of Rizatriptan for the treatment of pure menstrual migraine (PMM). Background.— In 2004, the International Headache Society proposed new research criteria for menstrual migraine (International Classification of Headache Disorders [ICHD-II]). Two subtypes were defined: PMM, in which attacks occur exclusively with menstruation, and menstrually related migraine (MRM), in which attacks may also occur at other times of the cycle. Methods.— The 2 protocols (MM1 and MM2) were identical randomized, double-blind studies. Adult patients with ICHD-II menstrual migraine were assigned to either Rizatriptan 10-mg tablet or placebo (2:1). Patients were to treat a single menstrual migraine attack of moderate or severe pain intensity. This prospectively planned substudy pooled data from patients with a diagnosis of PMM from both studies. The primary substudy endpoint was 2-hour pain relief. Efficacy data were summarized for patients with a diagnosis of MRM. Results.— Of 707 (MM1: 357, MM2: 350) patients treated in the study, 146 patients (MM1: 81, MM2: 65) had a diagnosis of PMM. The percentage of patients reporting 2-hour pain relief was significantly greater for Rizatriptan than for placebo for both PMM (73% vs 50%, P = .006) and MRM subgroups (71% vs 52%, P < .001). Most other efficacy endpoints favored Rizatriptan compared with placebo in patients with either PMM or MRM. Conclusion.— Rizatriptan 10 mg was superior to placebo for the treatment of PMM, as measured by 2-hour pain relief. Rizatriptan was also effective for the treatment of MRM and for relief of migraine-associated symptoms for both headache subtypes.

  • Efficacy and Tolerability of Coadministration of Rizatriptan and Acetaminophen vs Rizatriptan or Acetaminophen Alone for Acute Migraine Treatment
    Headache: The Journal of Head and Face Pain, 2008
    Co-Authors: Frederick G. Freitag, Anthony Rodgers, Merle L. Diamond, Seymour Diamond, Imke Janssen, Franck Skobieranda
    Abstract:

    Objective.—To evaluate the efficacy and tolerability of coadministration of Rizatriptan and acetaminophen in the acute treatment of migraine. Background.—Rizatriptan is a selective 5-HT1B/1D agonist approved for the acute treatment of migraine. Acetaminophen has been studied for acute migraine treatment. In consideration of the prominent central and peripheral mechanisms in migraine, the use of “multi-mechanism therapy” is gaining momentum in the treatment of acute migraine attacks. Study Design.—This was a randomized, double-blind, placebo-controlled trial conducted at 10 centers. Eligible patients with migraine according to International Headache Society criteria treated a single migraine attack of moderate or severe intensity within 4 h from pain onset. Patients were randomized into 1 of 4 groups (Rizatriptan 10 mg + acetaminophen 1000 mg [RA], Rizatriptan alone [R], acetaminophen alone [A], and placebo [P]). There were 3 co-primary hypotheses tested sequentially for 2-h pain relief: (1) RA would be superior to P; (2) if the first was fulfilled, RA would be superior to A; and (3) if the first 2 were fulfilled, RA would be superior to R. Results.—Of 173 patients who treated a migraine, 123 patients (71.5%) achieved pain relief within 2 h. RA (90%) was significantly better than P (46%) and A (70%), but only numerically better than R (77%) for 2-h pain relief. No significant differences were seen between the active treatment groups in adverse events. Conclusion.—Rizatriptan coadministered with acetaminophen achieved 2 of the 3 primary hypotheses,proving superior to both acetaminophen and placebo for 2-h pain relief, but failing to achieve superiority to Rizatriptan alone. RA was as well tolerated as each of the individual agents.

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