Long-term safety of rimegepant for treating migraines in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the long-term safety of rimegepant, a medication for the acute treatment of migraines, specifically in pediatric patients aged 6 to less than 18 years. Participants must have a history of migraines and experience a certain number of moderate to severe attacks monthly. The study aims to gather data on the safety profile of rimegepant over an extended period, ensuring that it is a viable treatment option for children and adolescents suffering from migraines.

Why it matters

Who can join: the full rules

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.

Where it's running

• Perseverance Research Center, LLC
  Scottsdale, Arizona, United States Recruiting
• Advanced Research Center, Inc.
  Anaheim, California, United States Recruiting
• Neuro-Pain Research Center
  Fresno, California, United States Recruiting
• Altman Clinical and Translational Research Institute, University of California San Diego
  La Jolla, California, United States Recruiting
• Adult & Child Neurology Medical Associates
  Long Beach, California, United States Recruiting
• Memorialcare Miller Children's & Women's Hospital Long Beach
  Long Beach, California, United States Recruiting

+74 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rimegepant 75 mg ODT for acute migraine in adults in India

  A single-arm study in adults in India will test whether a 75 mg orally disintegrating tablet of rimegepant is safe to use for treating a migraine attack when triptans didn’t work or can’t be used.

  Recruiting at 6 sites Phase 4 Pfizer · Visakhapatnam, Andhra Pradesh and 6 other locations · NCT07685769

• Second dose of rimegepant for acute migraine in adults

  This study tests whether taking a second 75 mg dose of rimegepant is safe and tolerable for adults who still have pain after an initial dose to treat an acute migraine attack.

  Recruiting at 19 sites Phase 4 Pfizer · Canoga Park, California and 23 other locations · NCT07609914

• Zavegepant (nasal spray) for treating migraine in children 6 to under 12

  This trial will test a single weight-based dose of zavegepant nasal spray to see how safe it is and how the medicine is processed in children 6 to under 12 with migraine.

  Recruiting at 11 sites Phase 1 Pfizer · Washington D.C., District of Columbia and 13 other locations · NCT06995729

• Daily rimegepant for chronic migraine prevention

  A 12-week test to see if taking rimegepant by mouth every day can reduce monthly migraine days in adults with chronic migraine compared with placebo.

  Recruiting at 18 sites Phase 3 Pfizer · Scottsdale, Arizona and 20 other locations · NCT07729462

• Long-term safety test of elismetrep for acute migraine

  This study tests whether intermittent use of elismetrep is safe and tolerable over the long term for people who have migraine attacks.

  Recruiting at 113 sites Phase 3 TriGemX Bio, Inc. · Birmingham, Alabama and 112 other locations · NCT07674654

• Gepants for Acute Migraine in the Emergency Department

  This study tests whether rimegepant or zavegepant given in the ED can relieve an acute migraine for adults.

  Recruiting Phase 1 University of South Florida · Tampa, Florida · NCT07667621

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.