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Mark Obermann - One of the best experts on this subject based on the ideXlab platform.
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Safety and efficacy of prednisone versus placebo in short-term prevention of Episodic Cluster Headache: a multicentre, double-blind, randomised controlled trial.
The Lancet. Neurology, 2020Co-Authors: Mark Obermann, André Scherag, Claudia Ose, Steffen Nägel, Nilüfer Sonuc, Peter Storch, Charly Gaul, Andreas Böger, Torsten Kraya, Jan-peter JansenAbstract:Prednisone is commonly used for initial short-term therapy of Episodic Cluster Headaches before preventive medication such as verapamil becomes effective, but this strategy has not been tested in large randomised trials. We aimed to access the safety and efficacy of this treatment approach. This study was a multicentre, randomised, double-blind, placebo-controlled trial done in ten specialised Headache centres in Germany. Patients with Episodic Cluster Headaches who were aged between 18 and 65 years and within a current pain episode for not more than 30 days, received 100 mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days, or matching placebo (17 days total exposure). All patients received oral verapamil for long-term prevention, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19; patients then continued with verapamil 120 mg throughout the study. Randomisation was computer-generated at a 1:1 ratio by use of an interactive web-response system, with stratification according to age, sex, and participating site. Participants, investigators, and those assessing outcomes were unaware of treatment allocation. The primary endpoint was the mean number of attacks within the first week of treatment with prednisone compared with placebo. An attack was defined as a unilateral Headache with moderate-to-severe intensity of at least five on a numerical rating scale. All efficacy and safety analyses were done in the modified intention-to-treat (mITT) population, which consisted of all patients who had been randomly assigned to a trial group and received at least one dose of prednisone or placebo. The study was stopped early due to slow recruitment and expired funding. The study was registered with EudraCT (2011-006204-13) and with the German Clinical Trials Register (DRKS00004716). Between April 5, 2013, and Jan 11, 2018, 118 patients were enrolled in the study. Two patients dropped out immediately and 116 patients were randomly assigned (57 patients to prednisone and 59 patients to placebo); 109 patients were included in the mITT analysis (53 patients assigned to prednisone and 56 patients assigned to placebo). Participants in the prednisone group had a mean of 7·1 (SD 6·5) attacks within the first week compared with 9·5 (6·0) attacks in the placebo group (difference -2·4 attacks, 95% CI -4·8 to -0·03; p=0·002). Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of Cluster Headache). A total of 270 adverse events were observed: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were Headache, palpitations, dizziness, and nausea) and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and Headache). Oral prednisone was an effective short-term preventive therapy in our population of patients with Episodic Cluster Headache. Our findings support the use of prednisone as a first-line treatment in parallel to the up-titration of verapamil, although the efficacy of prednisone alongside other long-term prevention requires additional investigation. German Federal Ministry for Education and Research. Copyright © 2020 Elsevier Ltd. All rights reserved.
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safety and efficacy of prednisone versus placebo in short term prevention of Episodic Cluster Headache a multicentre double blind randomised controlled trial
Lancet Neurology, 2020Co-Authors: Mark Obermann, André Scherag, Claudia Ose, Steffen Nägel, Nilüfer Sonuc, Peter Storch, Charly Gaul, Andreas Böger, Torsten Kraya, Jan-peter JansenAbstract:Summary Background Prednisone is commonly used for initial short-term therapy of Episodic Cluster Headaches before preventive medication such as verapamil becomes effective, but this strategy has not been tested in large randomised trials. We aimed to access the safety and efficacy of this treatment approach. Methods This study was a multicentre, randomised, double-blind, placebo-controlled trial done in ten specialised Headache centres in Germany. Patients with Episodic Cluster Headaches who were aged between 18 and 65 years and within a current pain episode for not more than 30 days, received 100 mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days, or matching placebo (17 days total exposure). All patients received oral verapamil for long-term prevention, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19; patients then continued with verapamil 120 mg throughout the study. Randomisation was computer-generated at a 1:1 ratio by use of an interactive web-response system, with stratification according to age, sex, and participating site. Participants, investigators, and those assessing outcomes were unaware of treatment allocation. The primary endpoint was the mean number of attacks within the first week of treatment with prednisone compared with placebo. An attack was defined as a unilateral Headache with moderate-to-severe intensity of at least five on a numerical rating scale. All efficacy and safety analyses were done in the modified intention-to-treat (mITT) population, which consisted of all patients who had been randomly assigned to a trial group and received at least one dose of prednisone or placebo. The study was stopped early due to slow recruitment and expired funding. The study was registered with EudraCT (2011–006204–13) and with the German Clinical Trials Register (DRKS00004716). Findings Between April 5, 2013, and Jan 11, 2018, 118 patients were enrolled in the study. Two patients dropped out immediately and 116 patients were randomly assigned (57 patients to prednisone and 59 patients to placebo); 109 patients were included in the mITT analysis (53 patients assigned to prednisone and 56 patients assigned to placebo). Participants in the prednisone group had a mean of 7·1 (SD 6·5) attacks within the first week compared with 9·5 (6·0) attacks in the placebo group (difference −2·4 attacks, 95% CI −4·8 to −0·03; p=0·002). Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of Cluster Headache). A total of 270 adverse events were observed: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were Headache, palpitations, dizziness, and nausea) and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and Headache). Interpretation Oral prednisone was an effective short-term preventive therapy in our population of patients with Episodic Cluster Headache. Our findings support the use of prednisone as a first-line treatment in parallel to the up-titration of verapamil, although the efficacy of prednisone alongside other long-term prevention requires additional investigation. Funding German Federal Ministry for Education and Research.
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STUDY PROTOCOL Open Access Study protocol of Prednisone in Episodic Cluster Headache (PredCH): a randomized, double-blind,
2016Co-Authors: Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-christoph Diener, Mark ObermannAbstract:el group trial to evaluate study arms. Eligible patients with Episodic Cluster Headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German Headache clinics that Holle et al. BMC Neurology 2013, 13:9
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study protocol of prednisone in Episodic Cluster Headache predch a randomized double blind placebo controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add on therapy in the prophylactic treatment of Episodic c
BMC Neurology, 2013Co-Authors: Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-christoph Diener, Mark ObermannAbstract:Background: Episodic Cluster Headache (ECH) is a primary Headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a Cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of Cluster attacks in the beginning of a Cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a Cluster episode. Methods and design: PredCH is a prospective, randomized, double-blind, placebo-controlled trial with parallel study arms. Eligible patients with Episodic Cluster Headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German Headache clinics that specialize in the treatment of ECH. Discussion: PredCH is designed to assess whether oral prednisone added to first-line agent verapamil helps reduce the number and intensity of Cluster attacks in the beginning of a Cluster episode as compared to monotherapy with verapamil.
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Study protocol of Prednisone in Episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episo
BMC neurology, 2013Co-Authors: Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-christoph Diener, Mark ObermannAbstract:Background Episodic Cluster Headache (ECH) is a primary Headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a Cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of Cluster attacks in the beginning of a Cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a Cluster episode.
Claudia Ose - One of the best experts on this subject based on the ideXlab platform.
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Safety and efficacy of prednisone versus placebo in short-term prevention of Episodic Cluster Headache: a multicentre, double-blind, randomised controlled trial.
The Lancet. Neurology, 2020Co-Authors: Mark Obermann, André Scherag, Claudia Ose, Steffen Nägel, Nilüfer Sonuc, Peter Storch, Charly Gaul, Andreas Böger, Torsten Kraya, Jan-peter JansenAbstract:Prednisone is commonly used for initial short-term therapy of Episodic Cluster Headaches before preventive medication such as verapamil becomes effective, but this strategy has not been tested in large randomised trials. We aimed to access the safety and efficacy of this treatment approach. This study was a multicentre, randomised, double-blind, placebo-controlled trial done in ten specialised Headache centres in Germany. Patients with Episodic Cluster Headaches who were aged between 18 and 65 years and within a current pain episode for not more than 30 days, received 100 mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days, or matching placebo (17 days total exposure). All patients received oral verapamil for long-term prevention, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19; patients then continued with verapamil 120 mg throughout the study. Randomisation was computer-generated at a 1:1 ratio by use of an interactive web-response system, with stratification according to age, sex, and participating site. Participants, investigators, and those assessing outcomes were unaware of treatment allocation. The primary endpoint was the mean number of attacks within the first week of treatment with prednisone compared with placebo. An attack was defined as a unilateral Headache with moderate-to-severe intensity of at least five on a numerical rating scale. All efficacy and safety analyses were done in the modified intention-to-treat (mITT) population, which consisted of all patients who had been randomly assigned to a trial group and received at least one dose of prednisone or placebo. The study was stopped early due to slow recruitment and expired funding. The study was registered with EudraCT (2011-006204-13) and with the German Clinical Trials Register (DRKS00004716). Between April 5, 2013, and Jan 11, 2018, 118 patients were enrolled in the study. Two patients dropped out immediately and 116 patients were randomly assigned (57 patients to prednisone and 59 patients to placebo); 109 patients were included in the mITT analysis (53 patients assigned to prednisone and 56 patients assigned to placebo). Participants in the prednisone group had a mean of 7·1 (SD 6·5) attacks within the first week compared with 9·5 (6·0) attacks in the placebo group (difference -2·4 attacks, 95% CI -4·8 to -0·03; p=0·002). Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of Cluster Headache). A total of 270 adverse events were observed: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were Headache, palpitations, dizziness, and nausea) and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and Headache). Oral prednisone was an effective short-term preventive therapy in our population of patients with Episodic Cluster Headache. Our findings support the use of prednisone as a first-line treatment in parallel to the up-titration of verapamil, although the efficacy of prednisone alongside other long-term prevention requires additional investigation. German Federal Ministry for Education and Research. Copyright © 2020 Elsevier Ltd. All rights reserved.
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safety and efficacy of prednisone versus placebo in short term prevention of Episodic Cluster Headache a multicentre double blind randomised controlled trial
Lancet Neurology, 2020Co-Authors: Mark Obermann, André Scherag, Claudia Ose, Steffen Nägel, Nilüfer Sonuc, Peter Storch, Charly Gaul, Andreas Böger, Torsten Kraya, Jan-peter JansenAbstract:Summary Background Prednisone is commonly used for initial short-term therapy of Episodic Cluster Headaches before preventive medication such as verapamil becomes effective, but this strategy has not been tested in large randomised trials. We aimed to access the safety and efficacy of this treatment approach. Methods This study was a multicentre, randomised, double-blind, placebo-controlled trial done in ten specialised Headache centres in Germany. Patients with Episodic Cluster Headaches who were aged between 18 and 65 years and within a current pain episode for not more than 30 days, received 100 mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days, or matching placebo (17 days total exposure). All patients received oral verapamil for long-term prevention, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19; patients then continued with verapamil 120 mg throughout the study. Randomisation was computer-generated at a 1:1 ratio by use of an interactive web-response system, with stratification according to age, sex, and participating site. Participants, investigators, and those assessing outcomes were unaware of treatment allocation. The primary endpoint was the mean number of attacks within the first week of treatment with prednisone compared with placebo. An attack was defined as a unilateral Headache with moderate-to-severe intensity of at least five on a numerical rating scale. All efficacy and safety analyses were done in the modified intention-to-treat (mITT) population, which consisted of all patients who had been randomly assigned to a trial group and received at least one dose of prednisone or placebo. The study was stopped early due to slow recruitment and expired funding. The study was registered with EudraCT (2011–006204–13) and with the German Clinical Trials Register (DRKS00004716). Findings Between April 5, 2013, and Jan 11, 2018, 118 patients were enrolled in the study. Two patients dropped out immediately and 116 patients were randomly assigned (57 patients to prednisone and 59 patients to placebo); 109 patients were included in the mITT analysis (53 patients assigned to prednisone and 56 patients assigned to placebo). Participants in the prednisone group had a mean of 7·1 (SD 6·5) attacks within the first week compared with 9·5 (6·0) attacks in the placebo group (difference −2·4 attacks, 95% CI −4·8 to −0·03; p=0·002). Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of Cluster Headache). A total of 270 adverse events were observed: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were Headache, palpitations, dizziness, and nausea) and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and Headache). Interpretation Oral prednisone was an effective short-term preventive therapy in our population of patients with Episodic Cluster Headache. Our findings support the use of prednisone as a first-line treatment in parallel to the up-titration of verapamil, although the efficacy of prednisone alongside other long-term prevention requires additional investigation. Funding German Federal Ministry for Education and Research.
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STUDY PROTOCOL Open Access Study protocol of Prednisone in Episodic Cluster Headache (PredCH): a randomized, double-blind,
2016Co-Authors: Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-christoph Diener, Mark ObermannAbstract:el group trial to evaluate study arms. Eligible patients with Episodic Cluster Headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German Headache clinics that Holle et al. BMC Neurology 2013, 13:9
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study protocol of prednisone in Episodic Cluster Headache predch a randomized double blind placebo controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add on therapy in the prophylactic treatment of Episodic c
BMC Neurology, 2013Co-Authors: Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-christoph Diener, Mark ObermannAbstract:Background: Episodic Cluster Headache (ECH) is a primary Headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a Cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of Cluster attacks in the beginning of a Cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a Cluster episode. Methods and design: PredCH is a prospective, randomized, double-blind, placebo-controlled trial with parallel study arms. Eligible patients with Episodic Cluster Headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German Headache clinics that specialize in the treatment of ECH. Discussion: PredCH is designed to assess whether oral prednisone added to first-line agent verapamil helps reduce the number and intensity of Cluster attacks in the beginning of a Cluster episode as compared to monotherapy with verapamil.
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Study protocol of Prednisone in Episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episo
BMC neurology, 2013Co-Authors: Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-christoph Diener, Mark ObermannAbstract:Background Episodic Cluster Headache (ECH) is a primary Headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a Cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of Cluster attacks in the beginning of a Cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a Cluster episode.
André Scherag - One of the best experts on this subject based on the ideXlab platform.
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Safety and efficacy of prednisone versus placebo in short-term prevention of Episodic Cluster Headache: a multicentre, double-blind, randomised controlled trial.
The Lancet. Neurology, 2020Co-Authors: Mark Obermann, André Scherag, Claudia Ose, Steffen Nägel, Nilüfer Sonuc, Peter Storch, Charly Gaul, Andreas Böger, Torsten Kraya, Jan-peter JansenAbstract:Prednisone is commonly used for initial short-term therapy of Episodic Cluster Headaches before preventive medication such as verapamil becomes effective, but this strategy has not been tested in large randomised trials. We aimed to access the safety and efficacy of this treatment approach. This study was a multicentre, randomised, double-blind, placebo-controlled trial done in ten specialised Headache centres in Germany. Patients with Episodic Cluster Headaches who were aged between 18 and 65 years and within a current pain episode for not more than 30 days, received 100 mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days, or matching placebo (17 days total exposure). All patients received oral verapamil for long-term prevention, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19; patients then continued with verapamil 120 mg throughout the study. Randomisation was computer-generated at a 1:1 ratio by use of an interactive web-response system, with stratification according to age, sex, and participating site. Participants, investigators, and those assessing outcomes were unaware of treatment allocation. The primary endpoint was the mean number of attacks within the first week of treatment with prednisone compared with placebo. An attack was defined as a unilateral Headache with moderate-to-severe intensity of at least five on a numerical rating scale. All efficacy and safety analyses were done in the modified intention-to-treat (mITT) population, which consisted of all patients who had been randomly assigned to a trial group and received at least one dose of prednisone or placebo. The study was stopped early due to slow recruitment and expired funding. The study was registered with EudraCT (2011-006204-13) and with the German Clinical Trials Register (DRKS00004716). Between April 5, 2013, and Jan 11, 2018, 118 patients were enrolled in the study. Two patients dropped out immediately and 116 patients were randomly assigned (57 patients to prednisone and 59 patients to placebo); 109 patients were included in the mITT analysis (53 patients assigned to prednisone and 56 patients assigned to placebo). Participants in the prednisone group had a mean of 7·1 (SD 6·5) attacks within the first week compared with 9·5 (6·0) attacks in the placebo group (difference -2·4 attacks, 95% CI -4·8 to -0·03; p=0·002). Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of Cluster Headache). A total of 270 adverse events were observed: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were Headache, palpitations, dizziness, and nausea) and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and Headache). Oral prednisone was an effective short-term preventive therapy in our population of patients with Episodic Cluster Headache. Our findings support the use of prednisone as a first-line treatment in parallel to the up-titration of verapamil, although the efficacy of prednisone alongside other long-term prevention requires additional investigation. German Federal Ministry for Education and Research. Copyright © 2020 Elsevier Ltd. All rights reserved.
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safety and efficacy of prednisone versus placebo in short term prevention of Episodic Cluster Headache a multicentre double blind randomised controlled trial
Lancet Neurology, 2020Co-Authors: Mark Obermann, André Scherag, Claudia Ose, Steffen Nägel, Nilüfer Sonuc, Peter Storch, Charly Gaul, Andreas Böger, Torsten Kraya, Jan-peter JansenAbstract:Summary Background Prednisone is commonly used for initial short-term therapy of Episodic Cluster Headaches before preventive medication such as verapamil becomes effective, but this strategy has not been tested in large randomised trials. We aimed to access the safety and efficacy of this treatment approach. Methods This study was a multicentre, randomised, double-blind, placebo-controlled trial done in ten specialised Headache centres in Germany. Patients with Episodic Cluster Headaches who were aged between 18 and 65 years and within a current pain episode for not more than 30 days, received 100 mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days, or matching placebo (17 days total exposure). All patients received oral verapamil for long-term prevention, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19; patients then continued with verapamil 120 mg throughout the study. Randomisation was computer-generated at a 1:1 ratio by use of an interactive web-response system, with stratification according to age, sex, and participating site. Participants, investigators, and those assessing outcomes were unaware of treatment allocation. The primary endpoint was the mean number of attacks within the first week of treatment with prednisone compared with placebo. An attack was defined as a unilateral Headache with moderate-to-severe intensity of at least five on a numerical rating scale. All efficacy and safety analyses were done in the modified intention-to-treat (mITT) population, which consisted of all patients who had been randomly assigned to a trial group and received at least one dose of prednisone or placebo. The study was stopped early due to slow recruitment and expired funding. The study was registered with EudraCT (2011–006204–13) and with the German Clinical Trials Register (DRKS00004716). Findings Between April 5, 2013, and Jan 11, 2018, 118 patients were enrolled in the study. Two patients dropped out immediately and 116 patients were randomly assigned (57 patients to prednisone and 59 patients to placebo); 109 patients were included in the mITT analysis (53 patients assigned to prednisone and 56 patients assigned to placebo). Participants in the prednisone group had a mean of 7·1 (SD 6·5) attacks within the first week compared with 9·5 (6·0) attacks in the placebo group (difference −2·4 attacks, 95% CI −4·8 to −0·03; p=0·002). Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of Cluster Headache). A total of 270 adverse events were observed: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were Headache, palpitations, dizziness, and nausea) and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and Headache). Interpretation Oral prednisone was an effective short-term preventive therapy in our population of patients with Episodic Cluster Headache. Our findings support the use of prednisone as a first-line treatment in parallel to the up-titration of verapamil, although the efficacy of prednisone alongside other long-term prevention requires additional investigation. Funding German Federal Ministry for Education and Research.
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STUDY PROTOCOL Open Access Study protocol of Prednisone in Episodic Cluster Headache (PredCH): a randomized, double-blind,
2016Co-Authors: Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-christoph Diener, Mark ObermannAbstract:el group trial to evaluate study arms. Eligible patients with Episodic Cluster Headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German Headache clinics that Holle et al. BMC Neurology 2013, 13:9
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study protocol of prednisone in Episodic Cluster Headache predch a randomized double blind placebo controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add on therapy in the prophylactic treatment of Episodic c
BMC Neurology, 2013Co-Authors: Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-christoph Diener, Mark ObermannAbstract:Background: Episodic Cluster Headache (ECH) is a primary Headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a Cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of Cluster attacks in the beginning of a Cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a Cluster episode. Methods and design: PredCH is a prospective, randomized, double-blind, placebo-controlled trial with parallel study arms. Eligible patients with Episodic Cluster Headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German Headache clinics that specialize in the treatment of ECH. Discussion: PredCH is designed to assess whether oral prednisone added to first-line agent verapamil helps reduce the number and intensity of Cluster attacks in the beginning of a Cluster episode as compared to monotherapy with verapamil.
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Study protocol of Prednisone in Episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episo
BMC neurology, 2013Co-Authors: Dagny Holle, Jan Burmeister, André Scherag, Claudia Ose, Hans-christoph Diener, Mark ObermannAbstract:Background Episodic Cluster Headache (ECH) is a primary Headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a Cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of Cluster attacks in the beginning of a Cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a Cluster episode.
Jan-peter Jansen - One of the best experts on this subject based on the ideXlab platform.
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Safety and efficacy of prednisone versus placebo in short-term prevention of Episodic Cluster Headache: a multicentre, double-blind, randomised controlled trial.
The Lancet. Neurology, 2020Co-Authors: Mark Obermann, André Scherag, Claudia Ose, Steffen Nägel, Nilüfer Sonuc, Peter Storch, Charly Gaul, Andreas Böger, Torsten Kraya, Jan-peter JansenAbstract:Prednisone is commonly used for initial short-term therapy of Episodic Cluster Headaches before preventive medication such as verapamil becomes effective, but this strategy has not been tested in large randomised trials. We aimed to access the safety and efficacy of this treatment approach. This study was a multicentre, randomised, double-blind, placebo-controlled trial done in ten specialised Headache centres in Germany. Patients with Episodic Cluster Headaches who were aged between 18 and 65 years and within a current pain episode for not more than 30 days, received 100 mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days, or matching placebo (17 days total exposure). All patients received oral verapamil for long-term prevention, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19; patients then continued with verapamil 120 mg throughout the study. Randomisation was computer-generated at a 1:1 ratio by use of an interactive web-response system, with stratification according to age, sex, and participating site. Participants, investigators, and those assessing outcomes were unaware of treatment allocation. The primary endpoint was the mean number of attacks within the first week of treatment with prednisone compared with placebo. An attack was defined as a unilateral Headache with moderate-to-severe intensity of at least five on a numerical rating scale. All efficacy and safety analyses were done in the modified intention-to-treat (mITT) population, which consisted of all patients who had been randomly assigned to a trial group and received at least one dose of prednisone or placebo. The study was stopped early due to slow recruitment and expired funding. The study was registered with EudraCT (2011-006204-13) and with the German Clinical Trials Register (DRKS00004716). Between April 5, 2013, and Jan 11, 2018, 118 patients were enrolled in the study. Two patients dropped out immediately and 116 patients were randomly assigned (57 patients to prednisone and 59 patients to placebo); 109 patients were included in the mITT analysis (53 patients assigned to prednisone and 56 patients assigned to placebo). Participants in the prednisone group had a mean of 7·1 (SD 6·5) attacks within the first week compared with 9·5 (6·0) attacks in the placebo group (difference -2·4 attacks, 95% CI -4·8 to -0·03; p=0·002). Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of Cluster Headache). A total of 270 adverse events were observed: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were Headache, palpitations, dizziness, and nausea) and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and Headache). Oral prednisone was an effective short-term preventive therapy in our population of patients with Episodic Cluster Headache. Our findings support the use of prednisone as a first-line treatment in parallel to the up-titration of verapamil, although the efficacy of prednisone alongside other long-term prevention requires additional investigation. German Federal Ministry for Education and Research. Copyright © 2020 Elsevier Ltd. All rights reserved.
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safety and efficacy of prednisone versus placebo in short term prevention of Episodic Cluster Headache a multicentre double blind randomised controlled trial
Lancet Neurology, 2020Co-Authors: Mark Obermann, André Scherag, Claudia Ose, Steffen Nägel, Nilüfer Sonuc, Peter Storch, Charly Gaul, Andreas Böger, Torsten Kraya, Jan-peter JansenAbstract:Summary Background Prednisone is commonly used for initial short-term therapy of Episodic Cluster Headaches before preventive medication such as verapamil becomes effective, but this strategy has not been tested in large randomised trials. We aimed to access the safety and efficacy of this treatment approach. Methods This study was a multicentre, randomised, double-blind, placebo-controlled trial done in ten specialised Headache centres in Germany. Patients with Episodic Cluster Headaches who were aged between 18 and 65 years and within a current pain episode for not more than 30 days, received 100 mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days, or matching placebo (17 days total exposure). All patients received oral verapamil for long-term prevention, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19; patients then continued with verapamil 120 mg throughout the study. Randomisation was computer-generated at a 1:1 ratio by use of an interactive web-response system, with stratification according to age, sex, and participating site. Participants, investigators, and those assessing outcomes were unaware of treatment allocation. The primary endpoint was the mean number of attacks within the first week of treatment with prednisone compared with placebo. An attack was defined as a unilateral Headache with moderate-to-severe intensity of at least five on a numerical rating scale. All efficacy and safety analyses were done in the modified intention-to-treat (mITT) population, which consisted of all patients who had been randomly assigned to a trial group and received at least one dose of prednisone or placebo. The study was stopped early due to slow recruitment and expired funding. The study was registered with EudraCT (2011–006204–13) and with the German Clinical Trials Register (DRKS00004716). Findings Between April 5, 2013, and Jan 11, 2018, 118 patients were enrolled in the study. Two patients dropped out immediately and 116 patients were randomly assigned (57 patients to prednisone and 59 patients to placebo); 109 patients were included in the mITT analysis (53 patients assigned to prednisone and 56 patients assigned to placebo). Participants in the prednisone group had a mean of 7·1 (SD 6·5) attacks within the first week compared with 9·5 (6·0) attacks in the placebo group (difference −2·4 attacks, 95% CI −4·8 to −0·03; p=0·002). Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of Cluster Headache). A total of 270 adverse events were observed: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were Headache, palpitations, dizziness, and nausea) and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and Headache). Interpretation Oral prednisone was an effective short-term preventive therapy in our population of patients with Episodic Cluster Headache. Our findings support the use of prednisone as a first-line treatment in parallel to the up-titration of verapamil, although the efficacy of prednisone alongside other long-term prevention requires additional investigation. Funding German Federal Ministry for Education and Research.
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sumatriptan overuse in Episodic Cluster Headache lack of adverse events rebound syndromes drug dependence and tachyphylaxis
Functional Neurology, 2000Co-Authors: V Centonze, A Bassi, V Causarano, Lidia Dalfino, M A Cassiano, Angelo Centonze, Laura Fabbri, O AlbanoAbstract:This observational study was designed to examine the pattern of sumatriptan use in patients with Cluster Headache using more than the recommended daily dose of subcutaneously injected (s.c.) sumatriptan. Thirteen patients suffering from Episodic Cluster Headache were asked to record the characteristics of their attacks and drug intake for 1 year. All reported a high daily frequency of attacks (more than 3 per day) and the related overuse of s.c. sumatriptan. The results show that the overall incidence of adverse events among patients receiving sumatriptan injections for the treatment of Cluster Headache is low. The extended administration of this drug in Episodic Cluster Headache did not result in tolerance problems or tachyphylaxis. Only 4 patients experienced minor adverse events and recovered more slowly than the others. They suffered from migraine without aura and Cluster Headache, and showed a family history of migraine. Even though they must be viewed with caution, due to the observational nature of the study and the low number of patients included, these results suggest that the profile of sumatriptan may differ in Cluster Headache compared with migraine.
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Sumatriptan overuse in Episodic Cluster Headache: lack of adverse events, rebound syndromes, drug dependence and tachyphylaxis.
Functional neurology, 2000Co-Authors: V Centonze, A Bassi, V Causarano, Lidia Dalfino, M A Cassiano, Angelo Centonze, Laura Fabbri, O AlbanoAbstract:This observational study was designed to examine the pattern of sumatriptan use in patients with Cluster Headache using more than the recommended daily dose of subcutaneously injected (s.c.) sumatriptan. Thirteen patients suffering from Episodic Cluster Headache were asked to record the characteristics of their attacks and drug intake for 1 year. All reported a high daily frequency of attacks (more than 3 per day) and the related overuse of s.c. sumatriptan. The results show that the overall incidence of adverse events among patients receiving sumatriptan injections for the treatment of Cluster Headache is low. The extended administration of this drug in Episodic Cluster Headache did not result in tolerance problems or tachyphylaxis. Only 4 patients experienced minor adverse events and recovered more slowly than the others. They suffered from migraine without aura and Cluster Headache, and showed a family history of migraine. Even though they must be viewed with caution, due to the observational nature of the study and the low number of patients included, these results suggest that the profile of sumatriptan may differ in Cluster Headache compared with migraine.
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Use of high sumatriptan dosages during Episodic Cluster Headache: three clinical cases.
Headache, 1996Co-Authors: V Centonze, A Bassi, M A Cassiano, B. M. Polito, E. Attolini, C. Sabbà, G. Ricchetti, L. Cavazzuti, O AlbanoAbstract:The authors describe three patients with Episodic Cluster Headache whose attacks were all treated with subcutaneous sumatriptan. The patients described had a high frequency of attacks (more than two per day); therefore, far higher dosage of the drug was taken than commonly used in Cluster Headache. The patients did not experience any particular side effects, neither during the treatment period nor on abrupt withdrawal of the drug. Moreover, neither tachyphylaxis nor addiction were observed. The authors point out both the efficacy of sumatriptan, confirmed in all the treated attacks, and its safety even at higher dosages than recommended.