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

  • STATUS
    Recruiting
  • End date
    Oct 14, 2023
  • participants needed
    600
  • sponsor
    Biohaven Pharmaceuticals, Inc.
Updated on 26 July 2022
Investigator
Ashlee Meindersee
Primary Contact
Boeson Research GJT (0.8 mi away) Contact
+85 other location

Summary

The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of age).

Details
Condition Acute Treatment of Migraine
Treatment Rimegepant / BHV3000
Clinical Study IdentifierNCT04743141
SponsorBiohaven Pharmaceuticals, Inc.
Last Modified on26 July 2022

Eligibility

Yes No Not Sure

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 enrollment
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 Baseline Visit
Ability to distinguish between migraine and other types of headaches
Weight ≥ 40 kg at the Screening Visit
Adequate venous access for blood sampling
Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study)

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 major psychiatric disorder
Current diagnosis or history of substance abuse; positive drug test at Screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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