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

Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Acute Treatment of Migraine

Treatments: Drug: Rimegepant / BHV3000

Study type: Interventional

Funder types: Industry

Identifiers

NCT04743141

BHV3000-312

2020-003761-18 (Registry Identifier)

C4951003 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Rimegepant / BHV3000

Experimental group

Description:

BHV3000 (rimegepant) 75 mg or 50 mg ODT

Treatment:

Drug: Rimegepant / BHV3000