Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
ConditionMigraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorPfizer
About this trial
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
Eligibility criteria
Qualifiers
14 or less headache days per month during the 3 month period prior to the Screening Visit
6 or more migraine days during the Observation Period
14 or less headache days during the Observation Period
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
Disqualifiers
Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
The subject has a history or diagnosis of complications of migraine
The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
Trial design
Treatments tested in this trial
- Rimegepant
- Placebo
Treatment groups
640 Participants
are divided into 2 treatment groupsLocations
91Canada
Children's and Women's Health Centre of British ColumbiaV6H 3V4, VancouverBritish Columbia, Canada
France
Centre Hospitalier Intercommunal de Creteil94000, Créteil France
Centre Hospitalier Universitaire de Montpellier34295, Montpellier France
Hopital des Enfants31059, Toulouse France
Sponsors and collaborators
Pfizer
Lead sponsor
Source ClinicalTrials.gov