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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 (Randomized Study in Children and Adolescents With Migraine: Acute Treatment)

Randomized Study in Children and Adolescents With Migraine: Acute Treatment (Randomized Study in Children and Adolescents With Migraine: Acute Treatment)

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Recruiting

April. 09, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-3 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).
2. 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.
3. 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.
a. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases.
b. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
c. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
4. Verbally distinguish between migraine and other types of headaches.
5. Participants must have a weight > 40 kg at the Screening Visit.
6. Adequate venous access for blood sampling.
7. Male and female participants >= 6 to < 18 years of age (participants must not reach their 18th birthday during the study).

1. History of cluster headache or hemiplegic migraine headache.
2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
3. 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.
4. History of suicidal behavior or major psychiatric disorder.
5. Current diagnosis or history of substance abuse; positive drug test at Screening.
6. 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.
7. Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
9. Current diagnosis of viral hepatitis or a history of liver disease.
10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Both

Migraine

BHV3000 (rimegepant) 75 mg or 50 mg or matched 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 :
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 ]
To compare rimegepant with placebo on freedom from phonophobia in adolescents, children and combined children and adolescents. [ Time Frame: 2 hours post-dose ]
To compare rimegepant with placebo on freedom from nausea in adolescents, children and combined children and adolescents. [ Time Frame: 2 hours post-dose ]
To compare rimegepant with placebo on pain relief in adolescents, children and combined children and adolescents. [ Time Frame: 2 hours post-dose ]
To compare rimegepant with placebo in adolescents, children and combined children and adolescents on pain relief. [ Time Frame: Time to patients first report of pain relief of none or mild post dose up to 48 hours. ]

+81-3-3251-0263

Oct. 27, 2023

Yes

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.

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