Status:
COMPLETED
Open Label Safety Study in Acute Treatment of Migraine
Lead Sponsor:
Pfizer
Conditions:
Migraine, With or Without Aura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).
Eligibility Criteria
Inclusion
- Key
- Subjects with 2-8 moderate to severe migraines/month
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4-72 hours if untreated
- Ability to distinguish migraine attacks from tension/cluster headaches
- Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria
- Key
Exclusion
- History of basilar migraine or hemiplegic migraine
- History of HIV disease
- History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia.
- Uncontrolled hypertension or uncontrolled diabetes (however, patients can be included who have stable hypertension and /or diabetes for 3 months prior to screening
- History of gastric or small intestinal surgery or has a disease that causes malabsorption
- BMI ≥ 30
- HbA1c ≥ 6.5%
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2019
Estimated Enrollment :
3019 Patients enrolled
Trial Details
Trial ID
NCT03266588
Start Date
August 30 2017
End Date
July 15 2019
Last Update
February 16 2023
Active Locations (98)
Enter a location and click search to find clinical trials sorted by distance.
1
Central Research Associates, Inc
Birmingham, Alabama, United States, 35205
2
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
3
Thunderbird Internal Medicine / Radiant Research, Inc
Glendale, Arizona, United States, 85306
4
Neurological Physicians of Arizona
Tempe, Arizona, United States, 85202