Status:
COMPLETED
A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache
Lead Sponsor:
Janssen-Ortho LLC
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 ea...
Detailed Description
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 stu...
Eligibility Criteria
Inclusion
- Diagnosis of migraine, with or without aura
- At least moderate pain with migraines
- Average of 2 to 6 migraines per month for past 3 months
- Duration of headache pain at least 4 hours
- Able to tell the difference between a migraine and a tension headache
- If taking a medication to prevent migraines, patients must have been taking a maintenance dose for at least 30 days before screening
- In generally good health
- If female, using birth control
Exclusion
- Routinely experience other type of headache that might seem like a migraine headache
- An average of 15 or more headache days per month in the past 6 months
- Migraines began after age 50
- Taking \> 1 medicine for preventing migraines
- Use of any drugs on list of prohibited drugs, of opioid drugs in past 7 days, of corticosteroids in the past 30 days, of an investigational drug within 30 days
- Use of non-drug treatment for migraine in past 14 days unless have used this treatment for \> 14 days and plan to continue throughout study
- Overuse of medications that treat pain or nausea
- Migraine aura without headache
- Hemiplegic or basilar migraines
- Usually have vomiting with headache
- Headaches that usually occur upon waking
- Significant unstable medical disease
- Abnormal liver, kidney, blood, or ECG laboratory or test results
- Abusing drugs or alcohol
- History of a significant mental disorder
- Pregnant or breast-feeding
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT00210509
Start Date
November 1 2004
End Date
June 1 2005
Last Update
May 17 2011
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