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Patrizia Santoro - One of the best experts on this subject based on the ideXlab platform.

Marco Bartolini - One of the best experts on this subject based on the ideXlab platform.

Andrew J Dowson - One of the best experts on this subject based on the ideXlab platform.

  • efficacy speed of action and tolerability of Almotriptan in the acute treatment of migraine pooled individual patient data from four randomized double blind placebo controlled clinical trials
    Cephalalgia, 2006
    Co-Authors: Carl Dahlof, David W Dodick, Jorge M Pascual, Andrew J Dowson
    Abstract:

    A meta-analysis of pooled individual patient data from four randomized, placebo-controlled, double-blind trials comparing several doses of Almotriptan (n = 1908) with placebo (n = 386) was used to investigate the efficacy, speed of onset and tolerability of Almotriptan in the acute treatment of migraine. As early as 30 min after dosing, Almotriptan 12.5 mg was significantly more effective than placebo for pain relief (14.9% vs. 8.2%; P < 0.05) and pain free (2.5% vs. 0.7%; P < 0.05). At 2 h, pain-relief rates were 56.0%, 63.7% and 66.0% for Almotriptan 6.25, 12.5 and 25 mg, respectively, compared with 35% for placebo; 2-h pain-free rates were 26.7%, 36.4% and 43.4% compared with 13.9% for placebo. All Almotriptan dosages were significantly more effective than placebo in eliminating migraine-associated symptoms (P < 0.05) and in achieving sustained pain relief up to 24 h (P < 0.05). The incidence of adverse events after Almotriptan 6.25 mg and 12.5 mg was not significantly different from that of placebo. T...

  • oral Almotriptan practical uses in the acute treatment of migraine
    Expert Review of Neurotherapeutics, 2004
    Co-Authors: Andrew J Dowson
    Abstract:

    Almotriptan (Almogran, Lundbeck; Almirall Prodesfarma; Axert, Ortho-McNeil) is a novel 5-HT(1B/1D) receptor agonist (triptan) that is widely available on prescription for the acute treatment of migraine. Almotriptan has pharmacodynamic and pharmacokinetic profiles that make it suitable for use in this indication. It is a potent agonist at 5-HT(1B), (1D) and (1F) receptors, while having a low affinity for other 5-HT receptors. It is also a potent inhibitor of neurogenic inflammation. Almotriptan has a high oral bioavailability, is absorbed rapidly, has a relatively short plasma half-life and its route of elimination presents few potential problems. Placebo-controlled dose-finding studies have demonstrated that Almotriptan tablets are effective and well-tolerated in the acute treatment of migraine, with a 12.5 mg dose providing the best balance between efficacy and tolerability. Large placebo-controlled studies show that the efficacy of oral Almotriptan is comparable with that of the other oral triptans. In direct comparator-controlled studies, Almotriptan was as effective as sumatriptan 50 and 100 mg but had a superior tolerability profile. Furthermore, the efficacy and tolerability of Almotriptan is sustained in the long term following open-label administration. Meta-analyses and post hoc analyses of clinical data confirm these findings. In conclusion, Almotriptan 12.5 mg is a good therapeutic choice for the symptomatic treatment of acute migraine attacks.

  • Almotriptan improves response rates when treatment is within 1 hour of migraine onset
    Headache, 2004
    Co-Authors: Andrew J Dowson, H Massiou, J M Lainez, X Cabarrocas
    Abstract:

    Background.—Results from open-label trials with Almotriptan and sumatriptan have shown higher response rates when treatment was initiated early after acute migraine onset. Objective.—To investigate the temporal component of early intervention by measuring 2-hour pain-free and sustained pain-free responses to Almotriptan and sumatriptan when the study drug was taken within 1 hour of onset of moderate to severe pain. Methods.—This was a post hoc analysis from a double-blind, randomized, placebo-controlled trial of Almotriptan and sumatriptan. Men and women, 18 to 65 years of age, who met International Headache Society criteria for migraine with or without aura were eligible. Patients were randomized to receive a single oral dose of Almotriptan 12.5 or 25 mg, sumatriptan 100 mg, or placebo at the onset of a severe or moderate migraine attack. For this post hoc analysis, the Almotriptan 25-mg dose was excluded because 12.5 mg is the recommended dose. The primary efficacy assessment was sustained pain-free, defined as pain-free at 2 hours postdose with no recurrence from 2 to 24 hours and no use of rescue medication. Only patients who took study medication within 1 hour of migraine onset were included in the analysis. Results.—Of the 475 patients involved in the original study, 253 (53.3%) initiated treatment within the 0- to 1-hour interval. For these patients, 2-hour pain-free rates were 37.9% for Almotriptan 12.5 mg (P= .016 versus placebo), 35.7% for sumatriptan 100 mg (P= .028 versus placebo), and 18.9% for placebo. Only Almotriptan was significantly higher than placebo on the sustained pain-free rate—34.7% (P= .022 versus placebo); the sustained pain-free rate for sumatriptan was 29.6% and for placebo, 17.0%. Conclusion.—Initiation of treatment with Almotriptan 12.5 mg within the first hour after acute migraine onset resulted in a significantly higher sustained pain-free response compared with placebo. There was no significant difference in sustained pain-free rates between sumatriptan and placebo. These results are consistent with those from a previous open-label trial, and suggest that early intervention with Almotriptan can improve clinical outcome.

  • Almotriptan is an effective and well tolerated treatment for migraine pain results of a randomized double blind placebo controlled clinical trial
    Cephalalgia, 2002
    Co-Authors: Andrew J Dowson, H Massiou, J M Lainez, X Cabarrocas
    Abstract:

    Almotriptan is a novel and specific serotonin 5-HT1B/1D agonist for the acute treatment of migraine. This randomized, single-dose, double-blind, multicentre, study assessed the efficacy and safety of oral Almotriptan (12.5 mg and 25 mg) in patients with migraine, and compared it with the standard treatment (sumatriptan 100 mg) and placebo. A total of 668 patients treated one migraine attack of moderate or severe intensity with study medication. The primary efficacy assessment was migraine pain relief, improvement from severe or moderate pain to mild or no pain, at 2 h after treatment. Response rates, stratified for variation in baseline pain levels, for both Almotriptan doses were equivalent to sumatriptan and significantly better than placebo. Other efficacy assessments confirmed the equivalence of the Almotriptan groups with the sumatriptan group. Almotriptan 12.5 mg was as well tolerated as placebo (P=0.493) and significantly better tolerated than sumatriptan (P<0.001), in terms of the overall incidence of adverse events. There was no statistically significant difference in the incidence of adverse events between Almotriptan 25 mg and sumatriptan 100 mg (P=0.376). The results from this large clinical study indicate that the new, specific 5-HT1B/1D agonist, Almotriptan, is an effective and well-tolerated treatment for migraine pain.

  • how does Almotriptan compare with other triptans a review of data from placebo controlled clinical trials
    Headache, 2002
    Co-Authors: Carl Dahlof, Andrew J Dowson, David W Dodick, Julio Pascual
    Abstract:

    Almotriptan, the new selective 5-HT1B/1D agonist, has a higher oral bioavailability than any other triptan, with more than two thirds of the administered dose absorbed within the first hour both inside and outside of a migraine attack. Gender or the presence of food in the stomach does not affect its pharmacokinetic profile, and the compound has no clinically relevant interactions with other drugs. Among the available triptans, response rates at 2 hours range from 50% to 80%, with 20% to 50% of patients pain-free. Almotriptan 12.5 mg provides similar efficacy, with significant advantage over placebo at 30 minutes and a reliable consistency (75% in two of three attacks). Headache typically recurs in 25% to 45% of patients with most triptans. The recurrence rate with Almotriptan 12.5 mg, 18% to 27%, is among the lowest reported. The tolerability of Almotriptan 12.5 mg is close to that of placebo with a low incidence of central nervous system side effects and chest symptoms. In conclusion, Almotriptan's consistent pharmacokinetics and good efficacy, in combination with excellent tolerability, make it an attractive choice in the acute treatment of migraine attacks.

Ninan T Mathew - One of the best experts on this subject based on the ideXlab platform.

  • Efficacy and tolerability of Almotriptan in adolescents: a randomized, double-blind, placebo-controlled trial.
    Headache, 2008
    Co-Authors: Steven L. Linder, Ninan T Mathew, Roger K. Cady, Gary Finlayson, Gary Ishkanian, Donald W. Lewis
    Abstract:

    Objectives.— To assess the efficacy and safety of Almotriptan 6.25 mg, 12.5 mg, and 25 mg vs placebo for acute migraine treatment in adolescents. Patients and Methods.— In this double-blind, placebo-controlled, parallel-group, multicenter trial, 866 patients aged 12 to 17 years with a >1 year history of migraine (per International Headache Society criteria) were randomized to treat one migraine headache with Almotriptan 6.25 mg, 12.5 mg, 25 mg, or placebo. The primary efficacy endpoint was headache pain relief 2 hours after dosing, adjusted for baseline severity, with absence of nausea, photophobia, and phonophobia 2 hours after dosing as coprimary endpoints. Results.— The 2-hour pain-relief rate was significantly higher with Almotriptan 25 mg compared with placebo (66.7% vs 55.3%; P = .022). The incidence of nausea, photophobia, and phonophobia at 2 hours (adjusted for baseline pain intensity) for the Almotriptan 25 mg and placebo groups was not significantly different. The 2-hour pain-relief rates (unadjusted) were significantly higher with Almotriptan 6.25 mg (71.8%), 12.5 mg (72.9%), and 25 mg (66.7%) than with placebo (55.3%; P = .001, P  2%) of nausea, dizziness, and somnolence. Conclusions.— Oral Almotriptan was efficacious for relieving migraine headache pain in adolescents, with the 12.5-mg dose associated with the most favorable efficacy profile with respect to relieving headache pain and associated symptoms of migraine (photophobia and phonophobia). Almotriptan treatment was well tolerated in this adolescent population.

  • effect of early intervention with Almotriptan vs placebo on migraine associated functional disability results from the aegis trial
    Headache, 2008
    Co-Authors: Frederick G Freitag, Ninan T Mathew, Gary Finlayson, Timothy R Smith, Lian Mao, Pamela Wright, Marcia F T Rupnow, Steven Greenberg, David M Biondi
    Abstract:

    Objective.— To investigate the effect of early acute migraine intervention with Almotriptan vs placebo on functional disability and health-related quality of life (HRQoL) indicators. Design/Methods.— In this multicenter, double-blind, parallel-group trial, adults with international classification of headache disorders-defined migraine, with or without aura, were randomized 1:1 to treat 3 consecutive headaches with either Almotriptan 12.5 mg or placebo. Patients were instructed to take their study medication at the first sign of migraine headache pain of any intensity, within 1 hour of onset. Patients recorded level of functional disability (normal, disturbed, bed rest required, emergency room [ER]/hospitalization required) at baseline (pretreatment), 0.5, 1, 2, 4, and 24 hours posttreatment and at time of pain-free. Patients completed the Migraine Disability Assessment Scale (MIDAS) at randomization and completed the Migraine Quality-of-Life Questionnaire (MQoL) at 24 hours after each attack. Results.— Results are presented for 315 patients (160 Almotriptan, 155 placebo) in the evaluable for efficacy population. At 2 hours posttreatment of Attack 1, 54.4%, 32.5%, 13.1%, and 0%, respectively, of Almotriptan-treated patients reported normal function, disturbed function, bed rest required, and ER/hospitalization required compared with 38.1%, 45.2%, 16.1%, and 0.6%, respectively, of placebo-treated patients. The differences in level of functional disability between the 2 treatment groups were statistically significant at 2 hours (P = .007; Cochran-Mantel-Haenszel, stratified by center) and at 4 hours (P < .001). Resolution of pain was associated with a normal level of function; at 2 hours posttreatment, 91.7% of patients in the total population who achieved pain-free reported normal function compared with 44.8%, 8.0%, and 0% of patients with mild, moderate, and severe pain, respectively. The absence compared with the presence of photophobia, phonophobia, and nausea at 2 hours also was associated with less disability (P < .0001 for each symptom). Treatment with Almotriptan compared with placebo resulted in consistently better 24-hour MQoL scores with significant results for all 3 migraine headache attacks in the social function and feelings/concern domains. A logistic regression model determined that pretreatment functional level (P = .0117), pretreatment pain intensity (P = .0089), and pretreatment MIDAS score (P = .0152) were significant covariates of the proportion of patients who achieved normal function at 2 hours posttreatment. Conclusions.— Early treatment with Almotriptan within 1 hour of migraine pain onset significantly reduced levels of functional disability at 2 and 4 hours posttreatment compared with placebo. Consistency in improvement of HRQoL indicators was observed across 3 headaches treated.

  • early intervention with Almotriptan results of the aegis trial axert early migraine intervention study
    Headache, 2007
    Co-Authors: Ninan T Mathew, Gary Finlayson, Roger Cady, Timothy R Smith, James U Adelman, Lian Mao, Pamela Wright, Steven J Greenberg
    Abstract:

    Objective.—To evaluate prospectively the efficacy and safety of Almotriptan 12.5 mg as compared to placebo when administered within 1 hour of headache pain onset for the acute treatment of 3 migraine headaches. Background.—Although clinical trials have reported improved outcomes when triptans were used early or to treat mild pain, acceptance of this treatment strategy has been hampered by both efficacy and tolerability issues. Methods.—In this multicenter, double-blind, placebo-controlled, parallel-group trial, patients with IHS-migraine were randomized in a 1:1 ratio to treat 3 consecutive migraine attacks with either Almotriptan 12.5 mg or placebo. Patients were instructed to take their study medication at the first sign of headache pain of any intensity, within 1 hour of onset, and to record their symptoms at multiple time points during their headaches using a personal digital assistant. Clinical trial efficacy results for the first study headache and safety data for the entire study are presented. Results.—A total of 378 patients were randomized, 189 to each group; 162 Almotriptan-treated patients, and 155 placebo-treated patients were evaluable for efficacy. Almotriptan treatment, compared to placebo, resulted in a significantly greater proportion of patients achieving 2-hour pain free (37.0% vs 23.9%, P= .010), 2-hour pain relief (72.3% vs 48.4%, P < .001) and sustained pain free (24.7% vs 16.1%, P= .040). Significant differences in pain free (P= .026) and pain relief (P= .019) between Almotriptan and placebo also were observed at 1 hour. At 2 to 4 hours and 4 to 24 hours after treatment, the mean intensity of phonophobia and photophobia were significantly lower in the patients treated with Almotriptan compared to the placebo-treated patients. A greater proportion of patients treating with Almotriptan versus placebo reported normal functionality within 2 hours postdose (54.4% vs 38.1%, P= .007) and 4 hours postdose (74.5% vs 54.3%, P < .001). The percentage of patients experiencing 1 or more treatment-emergent adverse events (AE) was 9.8% for Almotriptan and 6.4% for placebo. The only treatment-emergent AEs that occurred with a frequency of at least 1% (equivalent to 2 or more patients) in the Almotriptan and placebo groups, respectively, were somnolence (1.1% and 2.3%), nausea (1.1% and 1.7%), vomiting (1.1% and 0.6%), and fatigue (1.1% and 0%). Conclusion.—Treatment with Almotriptan within 1 hour of migraine onset resulted in significantly better clinical outcomes than placebo and tolerability similar to placebo. Acute medications, such as Almotriptan, that are both effective and well tolerated may encourage patients to access acute treatment earlier.

  • efficacy and tolerability of Almotriptan in controlled clinical trials
    European Neurology, 2005
    Co-Authors: Ninan T Mathew
    Abstract:

    Seven triptans are now available for the acute treatment of migraine. While all of these agents have been shown to be safe and more or less well tolerated, they differ in ways that are clinically relevant to individual patients. Almotriptan has been investigated in approximately 3,500 patients enrolled in short-term clinical trials and 1,500 patients enrolled in long-term open-label trials. In a meta-analysis of placebo-controlled Almotriptan trials (n = 2,294), treatment with Almotriptan 12.5 mg results in a 2-hour pain-relief rate of 63.7% and a 2-hour pain-free rate of 36.4%. Almotriptan is associated with a rapid onset of action, with 30-min pain-relief and pain-free rates significantly better than placebo (p < 0.05). Direct comparator studies show the efficacy of Almotriptan 12.5 mg to be comparable to that of sumatriptan but Almotriptan is associated with superior tolerability. Trials assessing the efficacy of Almotriptan over multiple attacks show that this agent is associated with a consistent and persistent response, not differing from the first to the last attack, an important property for a medication used to treat a chronic condition such as migraine. Early intervention with Almotriptan enhances the activity of this agent. Treatment of mild pain with Almotriptan has resulted in 2-hour pain-free rates of 84 and 77% and a sustained pain-free rate of 67%. Early treatment (within 1 h) of moderate to severe headaches with Almotriptan also improves outcomes. In conclusion, clinical trials and post hoc analyses of such trials have shown Almotriptan to be effective and well tolerated for the acute treatment of migraine. Its placebo-like tolerability makes it a good choice for early intervention, a strategy associated with better patient outcomes.

  • Almotriptan increases pain free status in patients with acute migraine treated in placebo controlled clinical trials
    Headache, 2002
    Co-Authors: Ninan T Mathew
    Abstract:

    Objectives.—Evaluate the efficacy of a single oral dose of Almotriptan in achieving pain-free status during treatment of acute migraine attacks. Methods.—This pooled analysis (N=1321) used data from two randomized, placebo-controlled, phase III trials (studies A and B) to determine the proportion of patients with migraine achieving pain-free status 2 hours after a single oral dose of study medication (Almotriptan or placebo). Pain was assessed using a 4-point integer scale (0=no headache, 3=severe headache), and recorded in a patient self-assessment booklet. Results.—The proportion of patients pain-free at 2 hours after study medication was significantly greater with Almotriptan 6.25 mg (both studies P≤.002) and Almotriptan 12.5 mg (both studies P≤.001) than with placebo. In study A, 11.6% of patients taking Almotriptan 12.5 mg versus 2.5% of patients receiving placebo were pain-free at 1 hour (P=.016). At 1.5 hours, 26.8% of patients taking Almotriptan 12.5 mg versus 8.8% receiving placebo (P=.001) were pain-free, and at 2 hours, 38.4% on Almotriptan versus 11.3% on placebo were pain-free (P<.001). In study B, 23.8% of patients taking Almotriptan 12.5 mg were free from pain at 1.5 hours versus 10.2% receiving placebo (P<.001). At 2 hours, 39.2% taking Almotriptan 12.5 mg versus 15.3% receiving placebo were pain-free (P<.001). Increases in pain-free status with Almotriptan generally occurred in a dose-dependent manner. Conclusion.—Compared with placebo, Almotriptan 12.5 mg significantly increases the proportion of patients who are pain-free by as early as 1 hour, and consistently by 1.5 hours, after a single dose.

X Cabarrocas - One of the best experts on this subject based on the ideXlab platform.

  • ethanol does not significantly affect the bioavailability of Almotriptan an open randomized crossover single dose phase i clinical trial in healthy volunteers
    Principles and Practice of Constraint Programming, 2006
    Co-Authors: X Cabarrocas, M Salva, M Pavesi, J Costa
    Abstract:

    Objective: A number of clinical reports have revealed a link between the use of alcohol and the onset or exacerbation of migraine headaches. This open, randomized, crossover, single-dose, phase I clinical trial evaluated the possible pharmacokinetic interactions between a single oral dose of Almotriptan 12.5 mg, a 5-HT 1B/1D receptor agonist for the acute treatment of migraine, and ethanol in 16 healthy male volunteers. Tolerability and safety of this combined treatment were also assessed. Methods: Subjects received a crossed oral dose of Almotriptan (12.5 mg) with and without concomitant alcohol intake (target plasma concentration 0.8 g/kg) in two different treatment periods. Almotriptan was administered alone, while ethanol was diluted with orange juice, which was also given to the control group. There was a washout period of 7 days between treatments. Plasma levels of Almotriptan were analyzed using a sensitive and specific liquid chromatographic-tandem mass spectrometry method. Results: The 90% non-parametric confidence interval for the median t max of Almotriptan plus ethanol compared to Almotriptan alone (0.61/2.72) was outside the acceptable range (0.70 - 1.30), demonstrating that concomitant ethanol administration slightly increases the variability of absorption of Almotriptan 12.5 mg. In contrast, the main bioavailability criteria parameters, C max and AUC, which show the rate and extent of systemic absorption, were not affected by alcohol ingestion. Therefore, it is unlikely that concomitant ethanol intake would produce clinically relevant differences in the therapeutic effect of Almotriptan at the dose studied here. Tolerability of treatments was good throughout the entire study period. Conclusions: Almotriptan 12.5 mg, with or without concomitant alcohol ingestion, showed similar plasma concentrations after a single dose in healthy volunteers with no clinically relevant drug-to-drug interactions.

  • efficacy and tolerability of Almotriptan versus zolmitriptan for the acute treatment of menstrual migraine
    Neurological Sciences, 2006
    Co-Authors: Gianni Allais, G Acuto, X Cabarrocas, R Esbri, Chiara Benedetto, Gennaro Bussone
    Abstract:

    : Menstrual migraine (MM) attacks are a challenge for the headache specialist, because they are particularly difficult to treat. Almotriptan is a second-generation triptan successfully used for the acute treatment of migraine. No data on the efficacy and safety of Almotriptan in MM treatment have been published previously. The objective was to evaluate the efficacy and tolerability of Almotriptan in the symptomatic treatment of MM attacks and to compare these parameters to those obtained with zolmitriptan, another second-generation triptan. Data from a multicentre, multinational, randomised, double-blind, parallel clinical trial, conducted at 118 centres in 9 European countries, to evaluate the efficacy and tolerability of Almotriptan 12.5 mg vs. zolmitriptan 2.5 mg in the acute treatment of migraine were analysed retrospectively. Of the 1061 patients included, 902 were women and 255 of these treated a MM attack: 136 with Almotriptan and 119 with zolmitriptan. No significant difference between the two treatments was found. Two hours after dosing, 67.9% of Almotriptan-treated and 68.6% of zolmitriptan-treated patients had obtained pain relief; while 44.9% and 41.2%, respectively, were pain free. Recurrence rates 2-24 h after dosing were 32.8% for Almotriptan and 34.7% for zolmitriptan. Adverse events in the 24 h after dosing were reported by 19.8% of those taking Almotriptan and 23.1% of those taking zolmitriptan. In conclusion, Almotriptan is effective and safe in the treatment of MM attacks.

  • efficacy and tolerability of Almotriptan versus zolmitriptan for the acute treatment of menstrual migraine
    Neurological Sciences, 2006
    Co-Authors: Gianni Allais, G Acuto, X Cabarrocas, R Esbri, Chiara Benedetto, Gennaro Bussone
    Abstract:

    : Menstrual migraine (MM) attacks are a challenge for the headache specialist, because they are particularly difficult to treat. Almotriptan is a second-generation triptan successfully used for the acute treatment of migraine. No data on the efficacy and safety of Almotriptan in MM treatment have been published previously. The objective was to evaluate the efficacy and tolerability of Almotriptan in the symptomatic treatment of MM attacks and to compare these parameters to those obtained with zolmitriptan, another second-generation triptan. Data from a multicentre, multinational, randomised, double-blind, parallel clinical trial, conducted at 118 centres in 9 European countries, to evaluate the efficacy and tolerability of Almotriptan 12.5 mg vs. zolmitriptan 2.5 mg in the acute treatment of migraine were analysed retrospectively. Of the 1061 patients included, 902 were women and 255 of these treated a MM attack: 136 with Almotriptan and 119 with zolmitriptan. No significant difference between the two treatments was found. Two hours after dosing, 67.9% of Almotriptan-treated and 68.6% of zolmitriptan-treated patients had obtained pain relief; while 44.9% and 41.2%, respectively, were pain free. Recurrence rates 2-24 h after dosing were 32.8% for Almotriptan and 34.7% for zolmitriptan. Adverse events in the 24 h after dosing were reported by 19.8% of those taking Almotriptan and 23.1% of those taking zolmitriptan. In conclusion, Almotriptan is effective and safe in the treatment of MM attacks.

  • effect of food intake on the bioavailability of Almotriptan an antimigraine compound in healthy volunteers an open randomized crossover single dose clinical trial
    Principles and Practice of Constraint Programming, 2006
    Co-Authors: Josep M Jansat, X Cabarrocas, Antonio Martineztobed, E Garcia, J Costa
    Abstract:

    This open, randomized, crossover, single-dose clinical trial evaluated the possible pharmacokinetic interaction between a single oral dose of Almotriptan 25 mg, a 5-HT 1B/1D receptor agonist for the acute treatment of migraine, and food intake in healthy volunteers. The influence of food intake in the rate and extent of Almotriptan absorption was evaluated by bioequivalence criteria. Tolerability and safety of treatment were also assessed. 16 healthy volunteers (8 men and 8 women, aged 19 - 27 years) received a crossed single oral dose of Almotriptan 25 mg under fasting and fed conditions, separated by a 7-day washout period. The treatment given under fasting condition was considered as reference. Plasma levels of Almotriptan were analyzed using high-performance liquid chromatography (HPLC) and UV detection at 227 nm. The 90% confidence intervals (CI) for the logarithmically transformed C max and AUC 0-∞ values of Almotriptan under fasting and fed conditions (97.8 - 124% and 102.9 - 108.2%, respectively) fell into the predetermined accepted range of 80 - 125%. No statistically significant differences in C max , t max , AUC 0-∞ , MRT and t 1/2 were observed under fasting and fed conditions between men and women. Tolerability of treatments was good throughout the whole study period. In conclusion, administration of Almotriptan 25 mg is bioequivalent under fasting and fed conditions in healthy men and women. Therefore, it is unlikely that concomitant food intake would produce clinically relevant differences in therapeutic effect with Almotriptan at the dose studied here.

  • pharmacokinetics and safety of oral Almotriptan in healthy male volunteers
    Biopharmaceutics & Drug Disposition, 2004
    Co-Authors: J Mcewen, M Salva, J M Jansat, X Cabarrocas
    Abstract:

    Almotriptan (LAS 31416) is a new, oral, specific 5-hydroxytryptamine(1B/1D) receptor agonist for the treatment of migraine. The pharmacokinetics and safety of a range of oral doses were assessed in 23 healthy male volunteers. Peak plasma concentrations were reached between 1.5 and 4 h after dosing. The maximum plasma concentration and area under the curve showed dose proportionality over the dose range 5-200 mg. The elimination half-life was constant at approximately 3 h across all dose levels. A substantial proportion of the initial dose was excreted in urine (27%-39%) during 12 h post-dose and the main excretory product was unchanged drug. Three major urinary metabolites were detected, all of which were pharmacologically inactive. The most common events following Almotriptan administration were headache, tiredness and mild nausea. Nine events (18%) were classed as probably related to Almotriptan and these were all at the highest dose level of 200 mg. The maximum tolerated dose of Almotriptan was, therefore, determined as 150 mg. In conclusion, Almotriptan is well tolerated following single, oral doses up to 150 mg and has predictable pharmacokinetics.