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Sponsors and Collaborators: |
Janssen-Ortho LLC Ortho-McNeil Neurologics, Inc. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Janssen-Ortho LLC |
ClinicalTrials.gov Identifier: | NCT00210496 |
The purpose of this study is to evaluate the impact of topiramate (migraine prevention medicine) on the effectiveness of almotriptan malate (acute migraine medicine) when treating acute migraine headaches.
Condition | Intervention | Phase |
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Migraine Common Migraine Classic Migraine |
Drug: topiramate; almotriptan malate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of AXERT (Almotriptan Malate) in the Acute Treatment of Migraine: A Pilot Study of the Potential Impact of Preventive Therapy With TOPAMAX (Topiramate) |
Estimated Enrollment: | 150 |
Study Start Date: | June 2005 |
Study Completion Date: | June 2007 |
Migraine afflicts greater than 28 million adults in the United States. Acute treatments, such as almotriptan malate, target the symptoms of a migraine attack. Preventive treatments, such as topiramate, primarily target the generation of attacks and may decrease use of acute treatments. Preventive treatments, by a process of neurostabilization, may result in an additive effect on almotriptan malate to improve acute treatment intervention response during a migraine attack. This is a randomized, double blind, parallel group multicenter study that will enroll patients 18-65 years old with a history of 3-12 migraine headaches each month for the past 3 months. The total study duration will be approximately 32 weeks. The study is divided into 4 phases as follows: A Screening Phase that lasts one month; An Open Label Phase where all patients will be treated with topiramate gradually dosed to 100mg a day lasting 6 weeks; A Double Blind Phase lasting 19 weeks at which time patients will be randomized to stay on topiramate 100mg per day or switch to placebo topiramate (50:50 chance) and a Taper/Exit Phase lasting 2 weeks. Almotriptan malate will be used for all migraine headaches during the study as needed. The study hypothesis is that the combination of almotriptan malate and topiramate will have a better clinical response than the combination of almotriptan malate and placebo topiramate. Migraine pain information will be collected from each patient with the use of a Personal Digital Assistant (PDA or Palm Pilot) throughout the study for each migraine attack.
Commercial Topiramate will be gradually increased to 100mg/day in approximately 4-6 weeks. You will then be randomized to either Topiramate or Placebo, dosed at 100mg a day, for the remainder of the study (18 weeks).
AXERT 12.5mg may be taken to treat migraine headaches during the study.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR002875 |
Study First Received: | September 13, 2005 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00210496 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Migraine headache Topiramate, Almotriptan malate |
Serotonin Agonists Neurotransmitter Agents Almotriptan Central Nervous System Diseases Headache Disorders, Primary Brain Diseases Neuroprotective Agents Serotonin Headache Disorders |
Anti-Obesity Agents Basilar Artery Migraines Migraine Disorders Headache Topiramate Migraine with Aura Anticonvulsants Migraine without Aura |
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Almotriptan Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Brain Diseases Protective Agents Neuroprotective Agents |
Pharmacologic Actions Headache Disorders Anti-Obesity Agents Serotonin Agents Migraine Disorders Therapeutic Uses Topiramate Migraine with Aura Central Nervous System Agents Anticonvulsants Migraine without Aura |