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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04743141
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : September 6, 2022
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Acute Treatment of Migraine Drug: Rimegepant / BHV3000 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to <18 Years of Age.
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine Safety

Arm Intervention/treatment
Experimental: Rimegepant / BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Drug: Rimegepant / BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT

Primary Outcome Measures :
  1. The occurrence of treatment-emergent adverse events, serious adverse events [ Time Frame: 58 weeks ]
    To evaluate the safety and tolerability of rimegepant in children and adolescents (≥ 6 to < 18 years of age).

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. History of migraine (with or without aura) for ≥ 6 months before Screening
  2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment.
  3. 1 or more migraine days requiring treatment during the Observation Phase.
  4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit
  5. Ability to distinguish between migraine and other types of headaches.
  6. Weight ≥ 40 kg at the Screening Visit.
  7. Adequate venous access for blood sampling.
  8. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study)

Exclusion Criteria:

  1. History of cluster headache or hemiplegic migraine headache.
  2. Confounding and clinically significant pain syndrome
  3. 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).
  4. History of suicidal behavior or major psychiatric disorder.
  5. Current diagnosis or history of substance abuse; positive drug test at Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743141

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Contact: Elyse Stock 203-404-0410 clinicaltrials@biohavenpharma.com

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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04743141    
Other Study ID Numbers: BHV3000-312
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biohaven Pharmaceuticals, Inc.:
Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases