NCT05156398 · Pfizer
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
What this study is about
The purpose of this study is to compare the effectiveness and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
View original scientific description
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.
Interventions
DRUG
Rimegepant
Rimegepant 75mg or 50mg (2 X 25mg) ODT
DRUG
Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Primary outcome measures
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Time frame: 3 months (12 weeks)
Reduction from baseline in mean number of migraine days per month
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Fort Smith, Arkansas
- Hawthorne, California
- La Mesa, California
- Colorado Springs, Colorado
- Fort Collins, Colorado
- Washington D.C., District of Columbia
- Edgewater, Florida
- Hialeah, Florida
- Hollywood, Florida
- Ormond Beach, Florida
- Tamarac, Florida
- Tampa, Florida
And 31 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations