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Phase III, randomized, double-blind, placebo-controlled, efficacy and safety clinical trial, followed by an open-label period, to investigate rimegepant in the prevention of migraine in adolescents aged 12 to less than 18 years.
THE PURPOSE OF THIS STUDY IS TO LEARN ABOUT THE EFFECTS OF THE STUDY DRUG (RIMEGEPANT) AND TO ASSESS THE SAFETY (THE IMPACT OF THE STUDY DRUG ON YOUR CHILD'S BODY) WHEN USED AS A PREVENTIVE TREATMENT FOR CHRONIC MIGRAINE.
Technical Summary
- PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PLACEBO-CONTROLLED, INTERVENTIONAL EFFICACY AND SAFETY STUDY, FOLLOWED BY AN OPEN-LABEL PERIOD, TO INVESTIGATE RIMEGEPANT IN THE PREVENTION OF MIGRAINE IN ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS WITH CHRONIC MIGRAINE.
- Code EudraCT: 2023-505601-16-00
- Protocol number: C4951013
- Promoter: Pfizer
- Molecule/Drug: RIMEGEPANT
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* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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