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Sponsors and Collaborators: |
Janssen-Ortho LLC Ortho-McNeil Neurologics, Inc. |
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Information provided by: | Janssen-Ortho LLC |
ClinicalTrials.gov Identifier: | NCT00210509 |
The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. Patients in this study will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.
Condition | Intervention | Phase |
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Migraine |
Drug: almotriptan malate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | AXERT® Early miGraine Intervention Study (AEGIS): Efficacy and Safety of Almotriptan Malate (AXERT®) Versus Placebo for the Acute Treatment of Migraine Headache |
Estimated Enrollment: | 316 |
Study Start Date: | November 2004 |
Study Completion Date: | June 2005 |
Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study of adult patients with a diagnosis of migraine headache, with or without aura. Patients will be randomized (like with the toss of a coin) to receive almotriptan malate (AXERT®) or placebo for the treatment of 3 consecutive qualifying migraine headaches. After screening, patients will leave the study center with blinded study medication and an electronic subject diary (Personal Digital Assistant [PDA]). Patients will self-dose with study medication as soon as headache pain of any intensity begins (that resembles their usual migraine), but no later than 1 hour after headache pain begins. Patients will use their PDAs to record assessments such as pain intensity, symptom severity and ability to function as related to the headaches. The primary hypothesis of this study is that the percentage of patients who are pain free two hours after taking study drug at the earliest onset of headache pain is greater in the almotriptan malate (AXERT®) 12.5mg group than in the placebo group and almotriptan malate (AXERT®) is generally well-tolerated.
Almotriptan malate (AXERT®) 12.5 milligrams or placebo tablets, one by mouth at the beginning of migraine pain (within 1 hour) for 3 consecutive migraine headaches
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: | CR004714 |
Study First Received: | September 13, 2005 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00210509 |
Health Authority: | United States: Food and Drug Administration |
pain aura headache Migraine |
Signs and Symptoms Migraine Disorders Almotriptan Headache Central Nervous System Diseases Neurologic Manifestations |
Headache Disorders, Primary Pain Brain Diseases Serotonin Headache Disorders |
Serotonin Agonists Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |