RecruitingPhase 3

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

CA

CO

CT

DC

FL

GA

IA

IL

IN

KS

KY

LA

MA

MI

MO

MT

NC

NE

NJ

NY

OH

OK

OR

PA

RI

SC

TN

TX

UT

VA

WA

WI