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 groupsSponsors and collaborators
Source ClinicalTrials.gov