RecruitingPhase 3

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

United States2,100 participantsStarted 2021-01-15

Plain-language summary

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

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 according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
✓. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours.
✓. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.
✓. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.
✓. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
✓. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
✓. Verbally distinguish between migraine and other types of headaches.
✓. Participants must have a weight \> 40 kg at the Screening Visit.

Exclusion criteria

✕. History of cluster headache or hemiplegic migraine headache.
✕. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
✕. Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
✕. History of suicidal behavior or major psychiatric disorder.
✕. Current diagnosis or history of substance abuse; positive drug test at Screening.
✕. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
✕. Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit.
✕. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).

What they're measuring

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.

Timeframe: 2 hours post-dose

Trial details

NCT IDNCT04649242

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01-09

Contact for this trial

Pfizer Pfizer CT.gov Call Center

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

View on ClinicalTrials.gov More Pediatric Migraine trials