Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Purpose
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Condition
- Pediatric Migraine
Eligibility
- Eligible Ages
- Between 6 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s). 2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting > 3 hours without treatment, and attacks occurring at intervals > 24 hours. 3. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study. 1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases. 2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited. 3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit. 4. Verbally distinguish between migraine and other types of headaches. 5. Participants must have a weight > 40 kg at the Screening Visit. 6. Adequate venous access for blood sampling. 7. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).
Exclusion Criteria
- History of cluster headache or hemiplegic migraine headache. 2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study. 3. Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania. 4. History of suicidal behavior or major psychiatric disorder. 5. Current diagnosis or history of substance abuse; positive drug test at Screening. 6. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning. 7. Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit. 8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding). 9. Current diagnosis of viral hepatitis or a history of liver disease. 10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator BHV3000 (active drug) |
BHV3000 (rimegepant) 75 mg or 50 mg ODT |
|
Placebo Comparator Placebo |
Matching 75 mg or 50 mg ODT placebo |
|
Recruiting Locations
Birmingham, Alabama 35244
Winston-Salem, North Carolina 27157
Portland, Oregon 97225
Portland, Oregon 97225
Portland, Oregon 97225
Grants Pass, Oregon 97527
Columbus, Ohio 43228
Columbus, Ohio 43214
Columbus, Ohio 43205
Cleveland, Ohio 44106
Cincinnati, Ohio 45242
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Akron, Ohio 44308
Greensboro, North Carolina 27405
Philadelphia, Pennsylvania 19104
Greensboro, North Carolina 27405
Charlotte, North Carolina 28211
Port Jefferson Station, New York 11776
New York, New York 10032
New York, New York 10032
New York, New York 10032
New York, New York 10032
New York, New York 10029
New York, New York 10003
Mineola, New York 11501
Mineola, New York 11501
Lake Success, New York 11042
Amherst, New York 14226
Portland, Oregon 97225
East Greenwich, Rhode Island 02818
Missoula, Montana 59804
Houston, Texas 77054
Kenosha, Wisconsin 53144
Bellevue, Washington 98007
Richmond, Virginia 23294
Norfolk, Virginia 23510
Norfolk, Virginia 23507
Charlottesville, Virginia 22902
Charlottesville, Virginia 22902
Charlottesville, Virginia 22902
Burlington, Vermont 05401
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
Plano, Texas 75093
Houston, Texas 77094
Dallas, Texas 75251
Charleston, South Carolina 29407
Dallas, Texas 75235
Dallas, Texas 75235
Dallas, Texas 75231
Bellaire, Texas 77401
Austin, Texas 78759
Austin, Texas 78757
Austin, Texas 78749
Austin, Texas 78723
Nashville, Tennessee 37203
Kingsport, Tennessee 37660
North Charleston, South Carolina 29405
Greenville, South Carolina 29615
Greenville, South Carolina 29607
Missoula, Montana 59804
Kalispell, Montana 59901
Phoenix, Arizona 85016
Upland, California 91786
Miami, Florida 33126
Lake City, Florida 32055
Gainesville, Florida 32607
Boca Raton, Florida 33486
Apopka, Florida 32703
Washington, District of Columbia 20010
Wilmington, Delaware 19803
Wilmington, Delaware 19803
Stamford, Connecticut 06905
Colorado Springs, Colorado 80907
Aurora, Colorado 80045
Aurora, Colorado 80045
Sacramento, California 95817
Miami, Florida 33176
Sacramento, California 95817
Sacramento, California 95816
Pomona, California 91767
North Hollywood, California 91606
Long Beach, California 90806
Lafayette, California 94549
La Jolla, California 92037
Fresno, California 93710
Culver City, California 90230
Banning, California 92220
Anaheim, California 92805
Tempe, Arizona 85284
Scottsdale, Arizona 85254
Miami, Florida 33176
Naples, Florida 34105
Helena, Montana 59601
New Orleans, Louisiana 70121
Helena, Montana 59601
Great Falls, Montana 59405
Great Falls, Montana 59405
Springfield, Missouri 65810
Ozark, Missouri 65721
Flowood, Mississippi 39232
Royal Oak, Michigan 48073
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Ann Arbor, Michigan 48104
Waltham, Massachusetts 02451
Boston, Massachusetts 02131
Overland Park, Kansas 66212
Naples, Florida 34105
Sioux City, Iowa 51106
Westfield, Indiana 46074
Noblesville, Indiana 46060
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Naperville, Illinois 60563
Chicago, Illinois 60657
Decatur, Georgia 30030
Brunswick, Georgia 31520
Atlanta, Georgia 30329
Atlanta, Georgia 30329
Tampa, Florida 33613
Orange Park, Florida 32073
Madison, Wisconsin 53792
More Details
- NCT ID
- NCT04649242
- Status
- Recruiting
- Sponsor
- Pfizer
Study Contact
Pfizer Pfizer CT.gov Call Center1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com