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Clinical Trials/jRCT2051240163
jRCT2051240163RecruitingNot Applicable

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

Pfizer Japan Inc.0 sites200 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Primary Endpoint
Number of migraine days per month
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Prevention Purpose
Masking
Double Blind

Eligibility Criteria

Ages
12age old over to 17age old under (—)
Sex
All

Inclusion Criteria

  • •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

  • •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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month(12 Weeks)
  • Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month(12 Weeks)
  • 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(12 weeks)
  • Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQLTM) total score(12 Weeks)
  • 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(12 Weeks)
  • 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(Up to 15 months)
  • 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(Up to 15 Months)
  • Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score(12 Weeks)

Investigators

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