RecruitingPhase 3

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

United States600 participantsStarted 2021-04-28

Plain-language summary

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).

Who can participate

Age range6 Years – 17 Years

SexALL

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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.

What they're measuring

The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities

Timeframe: 58 weeks

Trial details

NCT IDNCT04743141

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-07-31

Contact for this trial

Pfizer Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

View on ClinicalTrials.gov More Acute Treatment of Migraine trials