Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine
NCT ID: NCT06603623
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
647 participants
INTERVENTIONAL
2024-10-10
2025-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BHV-2100 75 mg
BHV-2100
BHV-2100 75mg
BHV-2100 150 mg
BHV-2100
BHV-2100 150 mg
Placebo
Placebo
matching placebo
Interventions
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BHV-2100
BHV-2100 75mg
BHV-2100
BHV-2100 150 mg
Placebo
matching placebo
Eligibility Criteria
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Inclusion Criteria
1. 2-8 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Period.
2. Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Period.
3. Participants on prophylactic migraine medication are permitted to remain on therapy they have been on a stable dose for at least 3 months prior to the Screening Visit.
Exclusion Criteria
2. Participants who have taken medication for acute treatment of headache (including triptans, ergotamine, opioids, acetaminophen, NSAIDs, or combination analgesics) on 10 or more days in any of the 3 months prior to screening.
3. Participants who have used a neuromodulation device for migraine treatment over the preceding 3 months before screening.
4. History of chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis, etc.), or individuals who have received anti-HCV treatment within 6 months prior to Screening.
5. Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. participants 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.
6. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however, participants can be included who have stable hypertension and/or stable diabetes for at least 3 months prior to being enrolled). A single blood pressure measurement of greater than 150 mm Hg systolic or 100 mm Hg diastolic after 10 minutes of rest is exclusionary.
7. Participant has a current diagnosis of major depression, other pain syndromes (e.g. chronic pelvic pain, chronic regional pain syndrome, fibromyalgia), psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
8. Participant has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.), or other disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
9. Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong CYP3A4 inhibitors or inducers.
10. Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong p-gp or BCRP inhibitors.
18 Years
64 Years
ALL
No
Sponsors
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Biohaven Therapeutics Ltd.
INDUSTRY
Responsible Party
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Locations
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MD First Research
Gilbert, Arizona, United States
WR-PRI, LLC (Encino)
Encino, California, United States
Cenexel CNS Los Alamitos
Los Alamitos, California, United States
Clinical Research Institute
Los Angeles, California, United States
WR-PRI, LLC (Newport Beach)
Newport Beach, California, United States
Cenexel CIT IE
Riverside, California, United States
Hasbani Neurology
New Haven, Connecticut, United States
Ki Health Partners DBA/ New England Institute for Clinical Research
Stamford, Connecticut, United States
Green Leaf Clinical Trials
Jacksonville, Florida, United States
WR-MSRA (Multi-Specialty Research Associates)
Lake City, Florida, United States
AppleMed Research Group
Miami, Florida, United States
Ideal Research
Pembroke Pines, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Premier Research Instiute
West Palm Beach, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Chicago Headache Center & Research Center
Chicago, Illinois, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, United States
Integrated Clinical Trials Services
West Des Moines, Iowa, United States
Collective Medical Research
Overland Park, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Crescent City Headache & Neurology
Chalmette, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Neurology Center of New England PC
Foxborough, Massachusetts, United States
MedVadis Research Corp
Waltham, Massachusetts, United States
Mass Institute of Clinical Research
Westborough, Massachusetts, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
StudyMedrix Research
City of Saint Peters, Missouri, United States
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri, United States
Clinvest Research
Springfield, Missouri, United States
WR-CRNC (Wake Research)
Las Vegas, Nevada, United States
ActivMed Practices & Research-Portsmouth/Pease
Portsmouth, New Hampshire, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Fieve Clinical Research, Inc.
New York, New York, United States
Rochester Clinical Research
Rochester, New York, United States
Velocity Clinical Research, Vestal
Vestal, New York, United States
PharmQuest Life Sciences
Greensboro, North Carolina, United States
Accellacare of Raleigh
Raleigh, North Carolina, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
OK Clinical Research, LLC
Edmond, Oklahoma, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Velocity Clinical Research, Columbia
Columbia, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
KCA Neurology
Franklin, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Zenos Clinical Research
Dallas, Texas, United States
DM Clinical Research - Belliare
Houston, Texas, United States
Red Star Research, LLC
Lake Jackson, Texas, United States
Epic Clinical Research
Lewisville, Texas, United States
DM Clinical Research - Tomball
Tomball, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Seattle Clinical Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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BHV2100-201
Identifier Type: -
Identifier Source: org_study_id
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