臨床研究等提出・公開システム

AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

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

Nov. 11, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

Inclusion Criteria:
*At least a 6 month history of migraine (with or without aura)
*15 or more headache days/month
*8 or more migraine days/month
*Migraine lasting 4-72 hours if untreated

Exclusion Criteria:
*Unrelenting headache
*Current psychiatric condition uncontrolled or untreated
*History of suicidal behavior or the subject is at risk of self-harm
*History of alcohol abuse and/or illicit drug use
*History of severe drug allergy
*Use of more than one medication for migraine prevention/prophylaxis
*Participation in another clinical trial at the same time

Both

Migraine

-Rimegepant 75 mg orally disintegrating tablets
-Matching placebo oral disintegrating tablets

*Number of migraine days per month [Time Frame: 12 Weeks]
-Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month

*Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month [Time Frame: 12 Weeks]
-Change in the use of acute migraine-specific medication days per month
*Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month [Time Frame: 12 Weeks]
-Change in headache days per month
*Efficacy of rimegepant relative to placebo measured as the percentage of participants with at least 50% reduction from baseline in number of moderate or severe migraine days per month [Time Frame: 12 weeks]
-Change in moderate or severe migraine days per month
*Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQLTM) total score [Time Frame: 12 Weeks]
-Change in the Quality of Life
*Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month [Time Frame: 12 Weeks]
-Change in headache and migraine rescue medication(s) used
*Safety of rimegepant relative to placebo, and safety of rimegepant given for a long period of time measured as the number and percentage of participants with adverse event by severity and overall [Time Frame: Up to 15 months]
-Safety and tolerability of the study drug
*Safety of rimegepant relative to placebo, and safety of rimegepant given for long period of time measured as the number and percentage of participants with liver-related adverse event and action taken [Time Frame: Up to 15 Months]
-Safety monitoring of adverse events of special interest
*Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score [Time Frame: 12 Weeks]
-Change in the Quality of Life

+81-6-6568-1601

Oct. 09, 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.

none