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Safety and Efficacy Study in Adult Subjects With Acute Migraines
Safety and Efficacy Study in Adult Subjects With Acute Migraines

NCT03235479

CompletedPhase 3

Sponsor: Pfizer

Conditions: Migraine, With or Without Aura

Interventions: Rimegepant, Placebo

Countries: United States

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

1. Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version\[1\] including the following:

   * Not more than 8 attacks of moderate or severe intensity per month within last 3 months
   * Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
2. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
3. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
4. Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

1. Patient history of HIV disease
2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
4. Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
5. Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal-absorption
6. The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
Locations (50)
  • Birmingham, Alabama, United States
  • Gilbert, Arizona, United States
  • Tempe, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Encino, California, United States
  • San Francisco, California, United States
  • Santa Monica, California, United States
  • Walnut Creek, California, United States
  • Hollywood, Florida, United States
  • Lake City, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Ormond Beach, Florida, United States
  • Savannah, Georgia, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • Marlborough, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Minneapolis, Minnesota, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • Norfolk, Nebraska, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Berlin, New Jersey, United States
  • Brooklyn, New York, United States
  • Endwell, New York, United States
  • + 20 more on CT.gov