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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 : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Parallel 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 : May 5, 2027

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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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


Outcome Measures
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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).


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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


Contacts
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Contact: Pfizer Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04743141    
Other Study ID Numbers: BHV3000-312
C4951003 ( Other Identifier: Alias Study Number )
2020-003761-18 ( Registry Identifier: CTIS (EU) )
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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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 Pfizer:
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