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Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Pfizer · NCT04743141

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
600
US sites recruiting
55
Study start
April 28, 2021
Record last updated
September 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Rimegepant (PF-07899801)

Conditions: Acute Treatment of Migraine

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • History of migraine (with or without aura) for ≥ 6 months before Screening.
  • History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
  • 1 or more migraine days requiring treatment during the Observation Phase.
  • Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
  • Ability to distinguish between migraine and other types of headaches.
  • Weight > 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of >25kg.
  • Adequate venous access for blood sampling.
  • 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

  • History of cluster headache or hemiplegic migraine headache.
  • Confounding and clinically significant pain syndrome.
  • 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).
  • History of suicidal behavior or at risk of self-harm/harm to others.
  • History of major psychiatric disorder.
  • Current diagnosis or history of substance abuse
  • Reported current use of or tested positive at Screening for drugs of abuse.

Recruiting US locations

Study contacts (from the official record)

  • Pfizer Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com
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Long-term Safety Study of Rimegepant in Pediatric Subjects for the… (NCT04743141) | Bored Studies