Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention 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 well rimegepant prevents migraines and how safe it is compared with a placebo (a treatment with no active medicine). It is for children and teens ages 6 to 17 who have migraines that come and go.
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Must be ages 6 to 17 when signing the study agreement.
- Must weigh at least 40 kg (about 88 pounds), or at least 15 kg (about 33 pounds) for the child group.
- Must have had migraines for at least 6 months, with or without aura (warning signs such as changes in vision).
- Must have had no more than 14 headache days per month during the 3 months before screening.
- During the study's observation period, must have at least 6 migraine days and no more than 14 headache days.
- Must have a migraine disability score of 11 to 50, meaning migraines cause mild or moderate trouble with daily activities.
- Must be able to explain how their migraines differ from other headaches. Untreated migraines must last 4 to 72 hours on average.
- If taking medicine to prevent migraines, the dose must have stayed the same for at least 12 weeks before screening and must not be expected to change during the study.
Who can't join
- A history of basilar migraine (a type with symptoms such as dizziness or trouble speaking), hemiplegic migraine (a type with muscle weakness), or cluster headaches.
- A nonstop migraine within the month before screening, or a history or diagnosis of health problems caused by migraines.
- A serious pain condition that could make it hard to take part in the study.
- A current mental health condition that has been uncontrolled or untreated for at least 6 months before screening.
- Any past psychosis (trouble knowing what is real), mania (extremely high mood or energy), or major mental health disorder.
- Past suicidal behavior, or a risk of harming themselves or others.
- Current or past substance abuse.
- Past moderate or severe head injury, another nervous system disorder such as seizures, or a body-wide illness that the study doctor thinks could affect brain or spinal cord function.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Subject has at least a 6 month history of migraine (with or without aura) and including the following: 1. 14 or less headache days per month during the 3 month period prior to the Screening Visit 2. 6 or more migraine days during the Observation Period 3. 14 or less headache days during the Observation Period 4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit 5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches 6. Migraine attacks, on average, lasting 4 - 72 hours if untreated 7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \<18 years; subjects must be less than 18 at the time of signing assent / consent. 3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit. Exclusion Criteria: 1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine 2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit. 3. The subject has a history or diagnosis of complications of migraine 4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study. 5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded. 6. History of suicidal behavior or the subject is at risk of self-harm or harm to others. 7. History of major psychiatric disorder. 8. The subject has a current diagnosis or history of substance abuse 9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.
Study sites (56)
AR
- The Belinga Clinic · Fort Smith, AR 72901More trials in Fort Smith
CA
- Advanced Investigative Medicine, Inc. · Hawthorne, CA 90250More trials in Hawthorne
- Velocity Clinical Research San Diego · La Mesa, CA 91942More trials in La Mesa
CO
- Colorado Springs Neurological Associates · Colorado Springs, CO 80907More trials in Colorado Springs
- Advanced Neurosciences Research, LLC · Fort Collins, CO 80528More trials in Fort Collins
DC
- Velocity Clinical Research, Washington DC · Washington D.C., DC 20016More trials in Washington D.C.
FL
- Accel Research Sites Network - Edgewater Clinical Research Unit · Edgewater, FL 32132More trials in Edgewater
- Direct Helpers Research Center · Hialeah, FL 33012More trials in Hialeah
- New Med Research, Inc · Hollywood, FL 33020More trials in Hollywood
- Complete Health Research · Ormond Beach, FL 32174More trials in Ormond Beach
- D&H Tamarac Research Center LLC · Tamarac, FL 33321More trials in Tamarac
- Santos Research Center, CORP · Tampa, FL 33615More trials in Tampa
GA
- Clinical Trial Office · Augusta, GA 30904More trials in Augusta
- Augusta University · Augusta, GA 30912More trials in Augusta
- WR-Mount Vernon Clinical Research, LLC · Sandy Springs, GA 30328More trials in Sandy Springs
- Meridian Clinical Research, LLC · Savannah, GA 31406More trials in Savannah
- Extraordinary Family Healthcare · Snellville, GA 30078More trials in Snellville
- Renew Health Clinical Research LLC · Snellville, GA 30078More trials in Snellville
ID
- Northwest Clinical Trials, Inc. · Boise, ID 83704More trials in Boise
IL
- Diamond Headache Clinic · Chicago, IL 60642More trials in Chicago
LA
- Nola Research Works, LLC · New Orleans, LA 70125More trials in New Orleans
MI
- NRST - Detroit · Detroit, MI 48203More trials in Detroit
MN
- Clinical Research Institute · Minneapolis, MN 55402More trials in Minneapolis
MO
- Roy Blunt NextGen Precision Health Building · Columbia, MO 65211More trials in Columbia
- University of Missouri Health Care - Investigation Pharmacy · Columbia, MO 65212More trials in Columbia
- University of Missouri-Clinical and Translational Sciences Unit · Columbia, MO 65212More trials in Columbia
- University of Missouri · Columbia, MO 65212More trials in Columbia
MS
- Safe Haven Clinical Research · Clinton, MS 39056More trials in Clinton
NC
- Carolina Institute for Clinical Research, LLC · Fayetteville, NC 28303More trials in Fayetteville
NE
- Velocity Clinical Research, Grand Island · Grand Island, NE 68803More trials in Grand Island
- Papillion Research Center/CCT Research · Papillion, NE 68046More trials in Papillion
NV
- Renown Regional Medical Center · Reno, NV 89502More trials in Reno
NY
- Dent Neurosciences Research Center, Inc. · Amherst, NY 14226More trials in Amherst
- Montefiore Medical Center · The Bronx, NY 10461More trials in The Bronx
OH
- Cincinnati Children's Hospital Medical Center · Cincinnati, OH 45229More trials in Cincinnati
- Velocity Clinical Research · Cincinnati, OH 45242More trials in Cincinnati
OK
- Lynn Health Science Institute · Oklahoma City, OK 73112More trials in Oklahoma City
SC
- Coastal Pediatric Research · Charleston, SC 29414More trials in Charleston
- Tribe Clinical Research LLC · Greenville, SC 29607More trials in Greenville
SD
- Avera McKennan Hospital & University Health Center · Sioux Falls, SD 57105More trials in Sioux Falls
- Avera Research Institute · Sioux Falls, SD 57108More trials in Sioux Falls
- Avera Medical Group Pediatrics - Dawley Farm · Sioux Falls, SD 57110More trials in Sioux Falls
TN
- Monroe Carell Jr Children's Hospital at Vanderbilt · Nashville, TN 37232More trials in Nashville
TX
- Alina Clinical Trials, LLC. · Dallas, TX 75209More trials in Dallas
- North Texas Center for Clinical Research · Frisco, TX 75034More trials in Frisco
- DM Clinical Research - Cy Fair · Houston, TX 77065More trials in Houston
- SCLA Management - Drop Box · Houston, TX 77077More trials in Houston
- SCLA Management Office · Houston, TX 77077More trials in Houston
- NeuroCare Plus · Houston, TX 77094More trials in Houston
- Red Star Research, LLC · Lake Jackson, TX 77566More trials in Lake Jackson
- DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials · McAllen, TX 78503More trials in McAllen
- DCT-Stone Oak, LLC dba Discovery Clinical Trials · San Antonio, TX 78258More trials in San Antonio
- Texas Institute for Neurological Disorders · Sherman, TX 75092More trials in Sherman
- DM Clinical Research (Administrative Office Only) · Tomball, TX 77375More trials in Tomball
- Victoria Clinical Research Group · Victoria, TX 77901More trials in Victoria
VA
- Meridian Clinical Research, LLC · Portsmouth, VA 23703More trials in Portsmouth