A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents >= 6 to <18 Years of Age
(Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects)
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects (Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects)
Kawai Norisuke
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
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
June. 03, 2024
June. 03, 2024
640
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
prevention purpose
Inclusion Criteria:
1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:
a. 14 or less headache days per month during the 3 month period prior to the Screening Visit
b. 6 or more migraine days during the Observation Period
c. 14 or less headache days during the Observation Period
d. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to <=50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
e. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
f. Migraine attacks, on average, lasting 4 - 72 hours if untreated
g. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects >= 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.
3)Subjects must have a weight of >=40 kg (child cohort requirement >=15 kg) at the Screening Visit.
Exclusion Criteria:
1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
3. The subject has a history or diagnosis of complications of migraine
4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
7. History of major psychiatric disorder.
8. The subject has a current diagnosis or history of substance abuse
9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.
6age old over
17age old under
Both
Migraine
Drug: Rimegepant
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Other Name: BHV3000
Drug: Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Other Name: Matching Placebo
Primary Outcome Measures :
1. Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine [ Time Frame: 3 months (12 weeks) ]
Reduction from baseline in mean number of migraine days per month
Secondary Outcome Measures :
1. Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine [ Time Frame: 3 months (12 weeks) ]
2. Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine. [ Time Frame: Weeks 1 through 4 of treatment ]
3. The mean change from baseline in the Pediatric Quality of Life (PedsQL TM) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine. [ Time Frame: Total score at week 12 ]
4. Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine. [ Time Frame: 3 months (12 weeks) ]
5. Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month. [ Time Frame: 3 months (12 weeks) ]
Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
6. Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days. [ Time Frame: 3 months (12 weeks) ]
Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.
7. Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents. [ Time Frame: 72 Weeks ]
This will be evaluated by the number of subjects with treatment related adverse events by severity.
8. Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant. [ Time Frame: 72 Weeks ]
Measured by discontinuations in treated subjects due to elevated liver function tests.
Pfizer Japan Inc.
Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
2-2-1 Kyobashi, Chuo-ku, Tokyo
Approval
Mar. 11, 2024
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.
