Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute 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 the long-term safety of rimegepant for treating migraine attacks when they happen. It is for children and teens ages 6 to 17.
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have had migraines for at least 6 months, with or without aura (warning signs such as changes in vision).
- Had 1 to 8 moderate or severe migraine attacks per month in the 2 months before screening.
- Have at least 1 migraine day that needs treatment during the study’s observation period.
- If taking medicine to prevent migraines, have stayed on the same dose for at least 12 weeks before screening.
- Can tell migraines apart from other headaches.
- Weigh more than 15 kg (about 33 pounds). In EU countries, those ages 12 to 17 must weigh more than 25 kg (about 55 pounds).
- Have veins that allow blood samples to be taken.
- Be age 6 to 17 and not turn 18 on or before the baseline visit.
Who can't join
- Have had cluster headaches or hemiplegic migraines (migraines with weakness on one side of the body).
- Have a serious pain condition that could make study results hard to judge.
- Have a mental health condition that has been untreated or not controlled for at least 6 months before screening.
- Have ever had psychosis (trouble knowing what is real) or mania (extremely high energy or mood).
- Have a history of suicidal behavior or a risk of harming yourself or others.
- Have had a major mental health disorder.
- Have a current or past substance abuse problem.
- Report current use of drugs of abuse or test positive for them at screening.
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. 2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening. 3. 1 or more migraine days requiring treatment during the Observation Phase. 4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit. 5. Ability to distinguish between migraine and other types of headaches. 6. Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg. 7. Adequate venous access for blood sampling. 8. Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit). Exclusion Criteria: 1. History of cluster headache or hemiplegic migraine headache. 2. Confounding and clinically significant pain syndrome. 3. Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded). 4. History of suicidal behavior or at risk of self-harm/harm to others. 5. History of major psychiatric disorder. 6. Current diagnosis or history of substance abuse 7. Reported current use of or tested positive at Screening for drugs of abuse.
Study sites (115)
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
- ProScience Research Group · Culver City, CA 90230More trials in Culver City
- Neuro-Pain Research Center · Fresno, CA 93710More trials in Fresno
- Altman Clinical and Translational Research Institute, University of California San Diego · La Jolla, CA 93037More trials in La Jolla
- Adult & Child Neurology Medical Associates · Long Beach, CA 90806More trials in Long Beach
- Memorialcare Miller Children's & Women's Hospital Long Beach · Long Beach, CA 90806More trials in Long Beach
- Velocity Clinical Research - North Hollywood · North Hollywood, CA 91606More trials in North Hollywood
- The Neurology Group · Pomona, CA 91767More trials in Pomona
- 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 Center · Sacramento, CA 95817More trials in Sacramento
- University of California, Davis Midtown Clinic · Sacramento, CA 95817More trials in Sacramento
- Velocity Clinical Research- Banning · 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- Investigational 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
- Boeson Research GJT · Grand Junction, CO 81501More trials in Grand Junction
- Dinosaur Pediatrics · Grand Junction, CO 81501More trials in Grand Junction
- Boeson Research GJT · Grand Junction, CO 81505More trials in Grand Junction
CT
- CT Clinical Research · Cromwell, CT 06416More trials in Cromwell
- 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.
FL
- 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
- Physicians Group Services, PA d/b/a Coastal Health Research · Orange Park, FL 32073More trials in Orange Park
- Clinical Associates of Orlando, LLC · Orlando, FL 32819More trials in Orlando
- 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
- 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
- Integrated Clinical Trial Services, Inc. · 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
KY
- University of Kentucky Hospital · Lexington, KY 40536More trials in Lexington
LA
- Ochsner Clinic Foundation · New Orleans, LA 70121More trials in New Orleans
MA
- MedVadis Research Corporation · Waltham, MA 02451More trials in Waltham
MI
- Michigan Head Pain and 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
MO
- Sharlin Health Neuroscience Research Center · Ozark, MO 65721More trials in Ozark
- Clinvest Research, LLC · Springfield, MO 65807More trials in Springfield
MT
- Boeson Research · Great Falls, MT 59405More trials in Great Falls
- 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
- 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 · 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
- New York Neurology Associates · New York, NY 10003More trials in New York
- Mount Sinai Hospital - Pharmacy Department · New York, NY 10029More trials in New York
- Columbia University Irving Medical 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
- North Suffolk Neurology · Port Jefferson Station, NY 11776More trials in Port Jefferson Station
OH
- WellNow Urgent Care and Research · Cincinnati, OH 45215More trials in Cincinnati
- Cincinnati Children's Hospital · Cincinnati, OH 45229More trials in Cincinnati
- Velocity Clinical Research - Cincinnati · Cincinnati, OH 45242More trials in Cincinnati
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106More trials in Cleveland
- Wellnow Urgent Care and Research · Dayton, OH 45424More trials in Dayton
OK
- IPS Research Company · Oklahoma City, OK 73106More trials in Oklahoma City
OR
- Velocity Clinical Research, Grants Pass · Grants Pass, OR 97527More trials in Grants Pass
- Providence Neuroscience Institute: Research Coordinators' Office · Portland, OR 97225More trials in Portland
- Providence Pediatric Specialty Clinic · 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
- Velocity Clinical Research- Greenville · Greenville, SC 29615More trials in Greenville
- Premier Neurology · Greer, SC 29650More trials in Greer
TN
- Novaceut Clinical Research · Clarksville, TN 37043More trials in Clarksville
- Le Bonheur Children's Hospital · Memphis, TN 37103More trials in Memphis
- Le Bonheur Childrens Hospital - Childrens Foundation Research Institute · Memphis, TN 38103More trials in Memphis
- Le Bonheur Childrens Hospital - Outpatient Building · 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
- Houston Clinical Trials, LLC · Bellaire, TX 77401More trials in Bellaire
- Infinite Research Group, LLC · Dallas, TX 75201More trials in Dallas
- Cedar Health Research · Dallas, TX 75251More 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
- Trio Clinical Trials, LLC. · Houston, TX 77008More 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
WA
- Northwest Clinical Research Center · Bellevue, WA 98007More trials in Bellevue
- Seattle Children's Hospital Investigational Drug Services · Seattle, WA 98105More trials in Seattle
- Seattle Children's Hospital · Seattle, WA 98105More trials in Seattle
WI
- University Hospital · Madison, WI 53792More trials in Madison