Migraine (with or without aura)
Conditions
Brief summary
Mean change from baseline (observation period, OP) in the number of migraine days per month over the entire DBT phase (Weeks 1 to 12) in adolescents with episodic migraine.
Detailed description
Percentage of participants with ≥50% reduction from the OP in the number of moderate to severe migraine days per month over the entire DBT phase in adolescents with episodic migraine., Mean change from the OP in the number of moderate to severe headache days per month over the entire DBT phase in adolescents with episodic migraine., Mean change from the OP in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT phase in adolescents with episodic migraine., Mean change from baseline in the Pediatric Quality of Life (PedsQLTM) total score at Week 12 of the DBT phase in adolescents with episodic migraine.
Interventions
DRUGRimegepant Placebo
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline (observation period, OP) in the number of migraine days per month over the entire DBT phase (Weeks 1 to 12) in adolescents with episodic migraine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with ≥50% reduction from the OP in the number of moderate to severe migraine days per month over the entire DBT phase in adolescents with episodic migraine., Mean change from the OP in the number of moderate to severe headache days per month over the entire DBT phase in adolescents with episodic migraine., Mean change from the OP in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT phase in adolescents with episodic migraine., Mean change from baseline in the Pediatric Quality of Life (PedsQLTM) total score at Week 12 of the DBT phase in adolescents with episodic migraine. | — |
Countries
France, Italy, Poland, Spain
Outcome results
None listed