Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
ConditionAcute Treatment of Migraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorPfizer
About this trial
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of migraine (with or without aura) for ≥ 6 months before Screening.
History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
1 or more migraine days requiring treatment during the Observation Phase.
Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
Disqualifiers
History of cluster headache or hemiplegic migraine headache.
Confounding and clinically significant pain syndrome.
Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
History of suicidal behavior or at risk of self-harm/harm to others.
Trial design
Design model
Single group
Treatments tested in this trial
Rimegepant (PF-07899801)
DrugRimegepant 75 mg, 50 mg or 35 mg ODT
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: ActiveExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities
To evaluate the safety and tolerability of rimegepant in children and adolescents (6 to \< 18 years of age).
Time frame
58 weeksSecondary outcomes
1
The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation
To evaluate the frequency and severity of hepatic-related adverse events and the frequency of hepatic-related treatment discontinuations in children and adolescents (6 to less than 18 years of age) treated with rimegepant.
Time frame
58 weeks Source ClinicalTrials.gov