Status:
COMPLETED
Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
Lead Sponsor:
Pfizer
Conditions:
Migraine
Acute Treatment of Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity l...
Detailed Description
Intervention Model: Parallel Versus Comparator + Placebo
Eligibility Criteria
Inclusion
- Key
- Patient with at least 1-year history of migraines (with or without aura) including the following:
- Migraine attacks more than 1 year with age of onset prior to 50 years of age
- Migraine attacks, on average, last about 4 - 72 hours if untreated
- No more than 8 attacks of moderate to severe intensity per month within last 3 months
- Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
- Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
- Male and female ≥ 18 years and ≤ age 65
- No clinically significant abnormality identified on the medical or laboratory evaluation
- Key
Exclusion
- Patient has a history of basilar migraine or hemiplegic migraine
- Patient does not receive migraine relief from triptan migraine treatment
- Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
- History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
- History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1026 Patients enrolled
Trial Details
Trial ID
NCT01430442
Start Date
October 1 2011
End Date
May 1 2012
Last Update
February 28 2023
Active Locations (41)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Clinical Res. Advantage Inc/ Desert Clinical Research Llc
Tempe, Arizona, United States, 85282
3
University Of California, San Francisco
San Francisco, California, United States, 94115
4
California Medical Clinic For Headache
Santa Monica, California, United States, 90404