RecruitingPhase 3

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

United States640 participantsStarted 2022-02-28

Plain-language summary

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.

Who can participate

Age range6 Years – 17 Years

SexALL

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Inclusion criteria

✓. Subject has at least a 6 month history of migraine (with or without aura) and including the following:
✓. 14 or less headache days per month during the 3 month period prior to the Screening Visit
✓. 6 or more migraine days during the Observation Period
✓. 14 or less headache days during the Observation Period
✓. 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
✓. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
✓. Migraine attacks, on average, lasting 4 - 72 hours if untreated
✓. 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.

Exclusion criteria

✕. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
✕. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
✕. The subject has a history or diagnosis of complications of migraine
✕. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
✕. 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.
✕. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
✕. History of major psychiatric disorder.
✕. The subject has a current diagnosis or history of substance abuse

What they're measuring

Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine

Timeframe: 3 months (12 weeks)

Trial details

NCT IDNCT05156398

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-11-29

Contact for this trial

Pfizer Pfizer CT.gov Call Center

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

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