Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 6 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe BHV-3000 is and how well it treats moderate or severe migraine attacks compared with a placebo (a treatment with no active medicine). It is for children and teens ages 6 to 17 who have had migraines for more than 6 months.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 6 to 17 and not turn 18 during the study.
- Have had migraines for more than 6 months, with or without aura (warning signs such as vision changes).
- Have had 1 to 8 moderate or severe migraine attacks per month in the past 2 months. Without treatment, attacks must last more than 3 hours and occur more than 24 hours apart.
- If taking medicine to prevent migraines, take only one allowed medicine. The dose must be unchanged for at least 12 weeks before the baseline visit and be expected to stay the same during the study.
- Do not use migraine medicines called CGRP blockers, such as erenumab or fremanezumab. Any past migraine prevention medicine must have been stopped at least 90 days before screening.
- Be able to explain the difference between migraines and other headaches.
- Weigh more than 40 kilograms (about 88 pounds) at screening.
- Have veins that allow blood samples to be taken.
Who can't join
- Have a history of cluster headaches or migraines that cause weakness on one side of the body.
- Have another serious pain condition that could make it hard to take part.
- Have a mental health condition that has been uncontrolled or untreated for at least 6 months before screening; or a history of a major mental health disorder, suicidal behavior, psychosis (loss of touch with reality), or mania (extreme high mood or energy).
- Have current or past substance abuse, or a positive drug test at screening.
- Have had a moderate or severe head injury, or have another brain or nerve disorder, including seizures, or a disease likely to affect brain and spinal cord function.
- Have recent or planned surgery needing general anesthesia (medicine that puts you to sleep), within the study’s stated 8-week limit before screening.
- Have had stomach or bowel surgery that affects how food moves through the body or how nutrients are absorbed.
- Have viral hepatitis (a liver infection), a history of liver disease, or another condition important to study safety, such as uncontrolled high blood pressure, diabetes, or a life-threatening allergy.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 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: 1. 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 sites (169)
AL
- Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama · Birmingham, AL 35244More trials in Birmingham
AZ
- Perseverance Research Center, LLC · Scottsdale, AZ 85253More trials in Scottsdale
- Physicians Research Group · Tempe, AZ 85284More trials in Tempe
CA
- Advanced Research Center, Inc. · Anaheim, CA 92805More trials in Anaheim
- Adult & Child Neurology Medical Associates · Costa Mesa, CA 92627More trials in Costa Mesa
- ProScience Research Group · Culver City, CA 90230More trials in Culver City
- Memorial Health Services · Fountain Valley, CA 92708More trials in Fountain Valley
- Neuro-Pain Research Center · Fresno, CA 93710More trials in Fresno
- Altman Clinical and Translational Research Institute, University of California San Diego · La Jolla, CA 92037More trials in La Jolla
- Adult & Child Neurology Medical Associates · Long Beach, CA 90806More trials in Long Beach
- Miller Children's & Women's Hospital Long Beach · Long Beach, CA 90806More trials in Long Beach
- National Research Institute · Los Angeles, CA 90057More trials in Los Angeles
- Velocity Clinical Research - North Hollywood · North Hollywood, CA 91606More trials in North Hollywood
- Children's Hospital of Orange County - Inpatient Pharmacy · Orange, CA 92868More trials in Orange
- Children's Hospital of Orange County - Neuroscience Center · Orange, CA 92868More trials in Orange
- Children's Hospital of Orange County · Orange, CA 92868More trials in Orange
- The Neurology Group · Pomona, CA 91767More trials in Pomona
- University of California, Davis Midtown Clinic · Sacramento, CA 95816More trials in Sacramento
- UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy · Sacramento, CA 95817More trials in Sacramento
- University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC) · Sacramento, CA 95817More trials in Sacramento
- Velocity Clinical Research, San Bernardino · San Bernardino, CA 92408More trials in San Bernardino
- Pacific Clinical Research Management Group LLC · Upland, CA 91786More trials in Upland
- Sunwise Clinical Research · Walnut Creek, CA 94596More trials in Walnut Creek
CO
- Children's Hospital Colorado- lnvestigational Drug Services · Aurora, CO 80045More trials in Aurora
- Children's Hospital Colorado · Aurora, CO 80045More trials in Aurora
- Colorado Springs Neurological Associates, PC · Colorado Springs, CO 80907More trials in Colorado Springs
- Colorado Springs Neurological Associates, PC · Colorado Springs, CO 80919More trials in Colorado Springs
CT
- CT Clinical Research · Cromwell, CT 06416More trials in Cromwell
- Connecticut Children's Medical Center · Hartford, CT 06106More trials in Hartford
- Ki Health Partners, LLc, dba New England Institute for Clinical Research · Stamford, CT 06905More trials in Stamford
DC
- Children's National Medical Center · Washington D.C., DC 20010More trials in Washington D.C.
DE
- Nemours Children's Hospital, Delaware · Wilmington, DE 19803More trials in Wilmington
FL
- Topaz Clinical Research, Inc. · Apopka, FL 32703More trials in Apopka
- Beautiful Minds Clinical Research Center · Cutler Bay, FL 33157More trials in Cutler Bay
- DeLand Clinical Research Unit · DeLand, FL 32720More trials in DeLand
- Sarkis Clinical Trials · Gainesville, FL 32607More trials in Gainesville
- Multi-Specialty Research Associates, Inc. · Lake City, FL 32055More trials in Lake City
- Watson Clinic Center for Research, Inc. · Lakeland, FL 33805More trials in Lakeland
- Watson Clinic LLP · Lakeland, FL 33805More trials in Lakeland
- AppleMed Research Group, LLC · Miami, FL 33126More trials in Miami
- Medical Research Center of Miami II, Inc · Miami, FL 33134More trials in Miami
- South Florida Research Phase I-IV, Inc · Miami, FL 33166More trials in Miami
- Brainstorm Research · Miami, FL 33176More trials in Miami
- Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office · Naples, FL 34102More trials in Naples
- Aqualane Clinical Research · Naples, FL 34105More trials in Naples
- Coastal Clinical Research Specialists · Orange Park, FL 32073More trials in Orange Park
- Clinical Associates of Orlando, LLC · Orlando, FL 32819More trials in Orlando
- Bioresearch Institute · Pembroke Pines, FL 33026More trials in Pembroke Pines
- Forcare Clinical Research · Tampa, FL 33613More trials in Tampa
- Premiere Research Institute at Palm Beach Neurology · West Palm Beach, FL 33407More trials in West Palm Beach
GA
- Children's Healthcare of Atlanta, Inc. · Atlanta, GA 30329More trials in Atlanta
- Childrens Healthcare of Atlanta · Atlanta, GA 30329More trials in Atlanta
- Rare Disease Research, LLC · Atlanta, GA 30329More trials in Atlanta
- Pivotal Clinical Research & Associates, LLC · Brunswick, GA 31520More trials in Brunswick
- CenExel iResearch, LLC · Decatur, GA 30030More trials in Decatur
IA
- Velocity Clinical Research, Sioux City · Sioux City, IA 51106More trials in Sioux City
- Integrated Clinical Trial Services · West Des Moines, IA 50265More trials in West Des Moines
IL
- Chicago Headache Center & Research Institute · Chicago, IL 60657More trials in Chicago
- AMR-Baber Research Inc · Naperville, IL 60563More trials in Naperville
IN
- Options Research Group, LLC · Westfield, IN 46074More trials in Westfield
KS
- Clinical Associates Midwest, LLC · Kansas City, KS 66214More trials in Kansas City
- College Park Family Care Center Physicians Group- Neurology Research Dept. · Overland Park, KS 66212More trials in Overland Park
KY
- Kentucky Neuroscience Institute Child Neurology-- "Patients Seen" · Lexington, KY 40504More trials in Lexington
- UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen" · Lexington, KY 40536More trials in Lexington
- University of Kentucky Hospital · Lexington, KY 40536More trials in Lexington
LA
- Ochsner Clinic Foundation · New Orleans, LA 70121More trials in New Orleans
- Neurology and Headache Center, Inc. · Shreveport, LA 71105More trials in Shreveport
MA
- Boston Clinical Trials · Boston, MA 02131More trials in Boston
- MedVadis Research Corporation · Waltham, MA 02451More trials in Waltham
MI
- Michigan Head Pain & Neurological Institute · Ann Arbor, MI 48104More trials in Ann Arbor
- Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group · Grand Rapids, MI 49503More trials in Grand Rapids
- Corewell Health, Helen DeVos Children's Hospital · Grand Rapids, MI 49503More trials in Grand Rapids
- Wellnow Urgent Care and Research · Kalamazoo, MI 49048More trials in Kalamazoo
- Beaumont Hospital Royal Oak Campus · Royal Oak, MI 48073More trials in Royal Oak
MN
- Brackenridge Outpatient Research Pharmacy · Rochester, MN 55905More trials in Rochester
- Clinical Research Trials Unit · Rochester, MN 55905More trials in Rochester
- Mayo Clinic · Rochester, MN 55905More trials in Rochester
MO
- Sharlin Health Neuroscience Research Center · Ozark, MO 65721More trials in Ozark
- Clinvest Research, LLC · Springfield, MO 65810More trials in Springfield
MS
- Precise Research Centers · Flowood, MS 39232More trials in Flowood
MT
- Boeson Research · Great Falls, MT 59405More trials in Great Falls
- Boeson Research · Kalispell, MT 59901More trials in Kalispell
- Heart & Hands Midwifery · Kalispell, MT 59901More trials in Kalispell
- Blue Moose Pediatrics · Missoula, MT 59804More trials in Missoula
- Boeson Research Laboratory · Missoula, MT 59804More trials in Missoula
- Boeson Research · Missoula, MT 59804More trials in Missoula
NC
- New Hope Clinical Research · Charlotte, NC 28211More trials in Charlotte
- OnSite Clinical Solutions, LLC · Charlotte, NC 28277More trials in Charlotte
- Headache Wellness Center, PC · Greensboro, NC 27405More trials in Greensboro
NE
- Alivation Research, LLC. · Lincoln, NE 68526More trials in Lincoln
- Children's Hospital & Medical Center · Omaha, NE 68114More trials in Omaha
NJ
- HMH Jersey Shore University Medical Center · Neptune City, NJ 07753More trials in Neptune City
- HOPE Tower at Jersey Shore University Medical Center · Neptune City, NJ 07753More trials in Neptune City
NY
- Dent Neurosciences Research Center · Amherst, NY 14226More trials in Amherst
- True North Neurology · Commack, NY 11725More trials in Commack
- Northwell Health IRB · Great Neck, NY 11021More trials in Great Neck
- Northwell Health Division of Pediatric Neurology Outpatient EEG Lab · Lake Success, NY 11042More trials in Lake Success
- Northwell Health/ Division of Pediatric Neurology · Lake Success, NY 11042More trials in Lake Success
- NYU Langone Hospital-Long Island, Clinical Research Center · Mineola, NY 11501More trials in Mineola
- NYU Langone Hospital-Long Island, Pediatric Neurology · Mineola, NY 11501More trials in Mineola
- New York Neurology Associates · New York, NY 10003More trials in New York
- Weill Cornell Medicine · New York, NY 10021More trials in New York
- Mount Sinai Hospital - Pharmacy Department · New York, NY 10029More trials in New York
- Columbia University Medical Center Research Pharmacy · New York, NY 10032More trials in New York
- Columbia University Pediatric Neuromuscular Center · New York, NY 10032More trials in New York
- Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit · New York, NY 10032More trials in New York
- The Neurological Institute of New York · New York, NY 10032More trials in New York
- The Trustees of Columbia University and The New York and Presbyterian Hospital · New York, NY 10032More trials in New York
- North Suffolk Neurology P.C · Port Jefferson Station, NY 11776More trials in Port Jefferson Station
- Finger Lakes Clinical Research · Rochester, NY 14618More trials in Rochester
- Prime Global Research, LLC · The Bronx, NY 10456More trials in The Bronx
OH
- Akron Children's Hospital · Akron, OH 44308More trials in Akron
- Cincinnati Children's Hospital Medical Center · Cincinnati, OH 45229More trials in Cincinnati
- Velocity Clinical Research · Cincinnati, OH 45242More trials in Cincinnati
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106More trials in Cleveland
- Nationwide Children's Hospital · Columbus, OH 43205More trials in Columbus
- Wellnow Urgent Care and Research · Columbus, OH 43228More trials in Columbus
- Neuro-Behavioral Clinical Research, Inc. · North Canton, OH 44720More trials in North Canton
OK
- IPS Research Company · Oklahoma City, OK 73106More trials in Oklahoma City
- Lynn Institute of Tulsa · Tulsa, OK 74135More trials in Tulsa
OR
- Velocity Clinical Research, Grants Pass · Grants Pass, OR 97527More trials in Grants Pass
- Providence Neuroscience Institute - Research Coordinator's Office · Portland, OR 97225More trials in Portland
- Providence St. Vincent Medical Center · Portland, OR 97225More trials in Portland
PA
- Clario · Philadelphia, PA 19103More trials in Philadelphia
- Children's Hospital of Philadelphia · Philadelphia, PA 19104More trials in Philadelphia
RI
- Velocity Clinical Research-Providence · East Greenwich, RI 02818More trials in East Greenwich
SC
- Premier Neurology, PC · Greenville, SC 29605More trials in Greenville
- Tribe Clinical Research, LLC · Greenville, SC 29607More trials in Greenville
- Velocity Clinical Research - Greenville · Greenville, SC 29615More trials in Greenville
TN
- Holston Medical Group. · Kingsport, TN 37660More trials in Kingsport
- Holston Medical Group · Kingsport, TN 37660More trials in Kingsport
- Le Bonheur Children's Hospital - Outpatient Building · Memphis, TN 38103More trials in Memphis
- Le Bonheur Children's Hospital · Memphis, TN 38103More trials in Memphis
- Le Bonheur Childrens Hospital - Childrens Foundation Research Institute · Memphis, TN 38103More trials in Memphis
- Access Clinical Trials, Inc. · Nashville, TN 37203More trials in Nashville
TX
- Dell Children's Medical Center · Austin, TX 78723More trials in Austin
- Child Neurology Consultants of Austin - South Austin · Austin, TX 78749More trials in Austin
- Child Neurology Consultants of Austin - Central Austin · Austin, TX 78757More trials in Austin
- BioBehavioral Research of Austin · Austin, TX 78759More trials in Austin
- Houston Clinical Trials, LLC · Bellaire, TX 77401More trials in Bellaire
- Infinite Research Group, LLC · Dallas, TX 75201More trials in Dallas
- Children's Medical Center, Dallas · Dallas, TX 75235More trials in Dallas
- Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only) · Dallas, TX 75235More trials in Dallas
- Cedar Health Research · Dallas, TX 75251More trials in Dallas
- FutureSearch Trials of Dallas, LLC · Dallas, TX 75251More trials in Dallas
- The University of Texas Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
- ANESC Research · El Paso, TX 79912More trials in El Paso
- North Texas Institute of Neurology and Headache · Frisco, TX 75034More trials in Frisco
- UTHealth Houston · Houston, TX 77030More trials in Houston
- Pain and Headache Centers of Texas · Houston, TX 77054More trials in Houston
- SCLA Management · Houston, TX 77077More trials in Houston
- Houston Clinical Research,LLC. · Houston, TX 77081More trials in Houston
- NeuroCare Plus · Houston, TX 77094More trials in Houston
- AIM Trials, LLC · Plano, TX 75093More trials in Plano
UT
- JBR Clinical Research · Salt Lake City, UT 84107More trials in Salt Lake City
- Wasatch Clinical Research , LLC(Administrative Location) · Salt Lake City, UT 84107More trials in Salt Lake City
VA
- Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice) · Charlottesville, VA 22902More trials in Charlottesville
- Pediatric Research of Charlottesville, LLC (Regulatory Only) · Charlottesville, VA 22902More trials in Charlottesville
- Pediatric Research of Charlottesville, LLC · Charlottesville, VA 22902More trials in Charlottesville
- Children's Hospital of the King's Daughters · Norfolk, VA 23507More trials in Norfolk
- CHKD Health Center · Norfolk, VA 23510More trials in Norfolk
- National Clinical Research, Inc. · Richmond, VA 23294More trials in Richmond
VT
- The University of Vermont Medical Center · Burlington, VT 05401More trials in Burlington
WA
- Northwest Clinical Research Center · Bellevue, WA 98007More trials in Bellevue
- Eastside Therapeutic Resource, Inc. dba Core Clinical Research · Everett, WA 98201More trials in Everett
- Seattle Children's Hospital Investigational Drug Services · Seattle, WA 98105More trials in Seattle
- Seattle Children's Hospital · Seattle, WA 98105More trials in Seattle
WI
- Clinical Investigation Specialists, Inc · Kenosha, WI 53144More trials in Kenosha
- University Hospital · Madison, WI 53792More trials in Madison