Clinical trial NCT06603623: Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine
Official title: Phase 2 Double-Blind, Randomized, Placebo Controlled, Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Migraine
Keywords: Acute Migraine
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 575
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to identify at least one dose of BHV-2100 that is safe and effective in reducing headache pain and other symptoms in the treatment of migraine.


Eligibility criteria: Key Inclusion Criteria:

Participants with at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition,19 including the following:

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.

Key Exclusion Criteria:

1. Participants with a history of basilar migraine or hemiplegic migraine.
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.

Primary outcomes:
measure: Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: Percentage of Participants With Pain Relief at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Return to Normal Function at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
timeFrame: From 2 hours up to 24 hours post-dose
measure: Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
timeFrame: From 2 hours up to 24 hours post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
measure: Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
timeFrame: 24 hours post-dose
measure: Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
timeFrame: From 2 hours up to 48 hours post-dose
measure: Observed Plasma concentration in Patients After a Single Dose of BHV-2100
timeFrame: At 2, 8, and 24 hours post-dose
measure: Number of Participants with Deaths, Serious AEs (SAEs), and moderate or severe AEs
timeFrame: Up to 11 weeks
measure: Number of Subjects with Clinically Significant Laboratory Abnormalities
timeFrame: Up to 11 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: MD First Research
state: Arizona
city: Encino
country: United States
facility: WR-PRI, LLC (Encino)
state: California
city: Los Alamitos
country: United States
facility: Cenexel CNS Los Alamitos
state: California
city: Los Angeles
country: United States
facility: Clinical Research Institute
state: California
city: Newport Beach
country: United States
facility: WR-PRI, LLC (Newport Beach)
state: California
city: Riverside
country: United States
facility: Cenexel CIT IE
state: California
city: New Haven
country: United States
facility: Hasbani Neurology
state: Connecticut
city: Stamford
country: United States
facility: Ki Health Partners DBA/ New England Institute for Clinical Research
state: Connecticut
city: Jacksonville
country: United States
facility: Green Leaf Clinical Trials
state: Florida
city: Lake City
country: United States
facility: WR-MSRA (Multi-Specialty Research Associates)
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group
state: Florida
city: Pembroke Pines
country: United States
facility: Ideal Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Premier Research Instiute
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research, Savannah
state: Georgia
city: Chicago
country: United States
facility: Chicago Headache Center & Research Center
state: Illinois
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Sioux City
country: United States
facility: Velocity Clinical Research, Sioux City
state: Iowa
city: West Des Moines
country: United States
facility: Integrated Clinical Trials Services
state: Iowa
city: Overland Park
country: United States
facility: Collective Medical Research
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Chalmette
country: United States
facility: Crescent City Headache & Neurology
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Rockville
country: United States
facility: Velocity Clinical Research, Rockville
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Foxboro
country: United States
facility: Neurology Center of New England PC
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corp
state: Massachusetts
city: Westborough
country: United States
facility: Mass Institute of Clinical Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research - Kansas City
state: Missouri
city: Saint Peters
country: United States
facility: StudyMedrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Las Vegas
country: United States
facility: WR-CRNC (Wake Research)
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research-Portsmouth/Pease
state: New Hampshire
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: New York
country: United States
facility: Fieve Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Vestal
country: United States
facility: Velocity Clinical Research, Vestal
state: New York
city: Greensboro
country: United States
facility: PharmQuest Life Sciences
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare of Raleigh
state: North Carolina
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research, LLC
state: Oklahoma
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Columbia
country: United States
facility: Velocity Clinical Research, Columbia
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Franklin
country: United States
facility: KCA Neurology
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Belliare
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research, LLC
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Tomball
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
Study officials:
References: