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

• ClinicalTrials.gov Identifier: NCT04743141
• Recruitment Status: Recruiting
• First Posted: February 8, 2021
• Last Update Posted: April 30, 2024
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: February 4, 2021
• First Posted Date: February 8, 2021
• Last Update Posted Date: April 30, 2024
• Actual Study Start Date: April 28, 2021
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 5, 2021)

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).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Treatment of Migraine

Intervention

Drug: Rimegepant / BHV3000

BHV3000 (rimegepant) 75 mg or 50 mg ODT

Study Arms

Experimental: Rimegepant / BHV3000

BHV3000 (rimegepant) 75 mg or 50 mg ODT

Intervention: Drug: Rimegepant / BHV3000

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 24, 2023): 200
• Original Estimated Enrollment (submitted: February 5, 2021): 600
• Estimated Study Completion Date: May 5, 2027
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Poland, Spain, United States

Administrative Information

• NCT Number: NCT04743141
• Other Study ID Numbers: BHV3000-312; C4951003 ( Other Identifier: Alias Study Number ); 2020-003761-18 ( Registry Identifier: CTIS (EU) )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Current Responsible Party: Pfizer
• Original Responsible Party: Biohaven Pharmaceuticals, Inc.
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Biohaven Pharmaceuticals, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2024