Recruiting NCT04649242

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Phase III Interventional Pediatric Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Rimegepant/BHV3000, Matching placebo.
Who it may be relevant to: Registry conditions: Pediatric Migraine. Basic parameters: 6 years — 17 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Canada, China, Japan, Mexico +4
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Overview

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.

Interventions

Drug Rimegepant/BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Drug Matching placebo
Matching 75 mg or 50 mg ODT placebo

Primary outcome measures

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain. [Time frame: 2 hours post-dose]

Secondary outcome measures (12)

To compare rimegepant with placebo for pain freedom in children and adolescents combined. [Time frame: 2 hours post-dose]
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents. [Time frame: 2 hours post-dose]
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents. [Time frame: Within 24 hours and 48 hours of initial treatment]
To compare rimegepant with placebo on sustained pain freedom in adolescents. [Time frame: 2 to 24 hours post-dose]
To compare rimegepant with placebo on sustained pain freedom in adolescents. [Time frame: 2 to 48 hours post-dose]
To compare rimegepant with placebo on the ability to function normally as reported on the Functional Disability scale in adolescents. [Time frame: 2 hours post-dose]
To compare rimegepant with placebo for pain freedom in children. [Time frame: 2 hours post-dose]
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents. [Time frame: 2 hours post-dose]
To compare rimegepant with placebo on the probabilities of requiring rescue medication in children and combined children and adolescents. [Time frame: Within 24 hours and 48 hours of initial treatment.]
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents. [Time frame: 2 to 24 hours post-dose]
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents. [Time frame: 2 to 48 hours post-dose]
To compare rimegepant with placebo on freedom from photophobia in adolescents, children and combined children and adolescents. [Time frame: 2 hours post-dose]

Eligibility criteria

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 8 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Sequential
Masking: Triple blind
Primary purpose: Treatment