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Open Label Safety Study in Acute Treatment of Migraine

NCT03266588

CompletedPhase 2, Phase 3

Sponsor: Pfizer

Conditions: Migraine, With or Without Aura

Interventions: Rimegepant

Countries: United States

The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* 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 Criteria:

* 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%

Locations (98)

Birmingham, Alabama, United States
Mobile, Alabama, United States
Glendale, Arizona, United States
Tempe, Arizona, United States
Tempe, Arizona, United States
Little Rock, Arkansas, United States
Rogers, Arkansas, United States
Encino, California, United States
La Mesa, California, United States
Long Beach, California, United States
Los Alamitos, California, United States
Newport Beach, California, United States
Oakland, California, United States
Panorama City, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Sherman Oaks, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Lake City, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Savannah, Georgia, United States
+ 68 more on CT.gov