RecruitingPhase 3

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

CA

CO

DC

FL

GA

ID

IL

LA

MI

MN

MO

MS

NC

NE

NV

NY

OH

OK

SC

SD

TN

TX

VA