Randomized Study in Children and Adolescents With Migraine: Acute Treatment

  • STATUS
    Recruiting
  • End date
    Jan 22, 2023
  • participants needed
    1440
  • sponsor
    Biohaven Pharmaceutical Holding Company Ltd.
Updated on 22 September 2021
Investigator
Yoce Aguilar
Primary Contact
AMITA St. Alexius Women and Children's Hospital (7.6 mi away) Contact
+109 other location
acute treatment
erenumab
migraine in children

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.

Details
Condition Migraine, Primary Stabbing Headache, Migraine (Adult), Migraine and Cluster Headaches, Migraine (Pediatric), migraines, Pediatric Migraine
Treatment Matching Placebo, Rimegepant/BHV3000
Clinical Study IdentifierNCT04649242
SponsorBiohaven Pharmaceutical Holding Company Ltd.
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

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 6 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
Adequate venous access for blood sampling
Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday during the study)

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)
Current diagnosis of viral hepatitis or a history of liver disease
Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
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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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