802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia
Megadott ok: Sponsor Decision
A legfontosabb adatok
- Fázis
- 3. fázis
A vizsgálat adatai
- Ki végzi
- Biogen
- Azonosító
- NCT03070132
- A regiszteradat frissítve
- 2023. május 6.
- Eredeti leírás
The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with trigeminal neuralgia (TN). Secondary objectives of this study are to investigate the safety and tolerability of BIIB074 in participants with TN and to evaluate the population pharmacokinetics (PK) of BIIB074.A teljes eredeti leírásKevesebb
A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia
The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with trigeminal neuralgia (TN). Secondary objectives of this study are to investigate the safety and tolerability of BIIB074 in participants with TN and to evaluate the population pharmacokinetics (PK) of BIIB074.
Bevonási feltételek: A diagnosis of trigeminal neuralgia (TN) for at least 3 months based on International Headache Society (IHS) diagnostic criteria; Participant must have failed at least 1 prior standard of care pharmacologic treatment for TN (defined as an inadequate response or intolerance to treatment), as determined by the Investigator based on medical history; Age ≥18 years at the time of informed consent; Allowed concomitant medications must have been stable for at least 4 weeks prior to Day 1 of the dose-optimization period. The maximum dosage of carbamazepine allowed on Day 1 is 400 mg/day (or 600 mg/day for oxcarbazepine); Participants must have recorded their pain score in their eDiary on at least 5 days during the run-in period (Days -7 to -1).
Kizáró feltételek: Has donated blood or blood products within a 30-day period prior to Screening; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply; History or positive test result at Screening for hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]); Positive history of human immunodeficiency virus (HIV) or a positive HIV test at Screening; Personal or family (first-degree relative) history of seizures (except for simple febrile convulsions) or clinically significant head injury; Known hypersensitivity to BIIB074 or components of the BIIB074 formulation or matching placebo; Participants with facial pain other than TN; Positive pregnancy test result at Screening (women of childbearing potential only).