802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia
Reason given: Sponsor Decision
Key facts
- Phase
- Phase 3
Trial details
- Who runs it
- Biogen
- Trial code
- NCT03637387
- Record updated
- 6 May 2023
- Original description
The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with trigeminal neuralgia (TN).Read full original descriptionShow less
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).
The secondary objectives are to investigate the safety and tolerability of BIIB074 in participants with TN and to evaluate the population pharmacokinetic(s) (PK) of BIIB074.
Inclusion: 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; Participants must have recorded their pain score in their eDiary on at least 5 days during the run-in period (Days -7 to -1); 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).
Exclusion: Positive drug screen for drugs of abuse at Screening (amphetamine [methamphetamines and 3,4-methylenedioxymethamphetamine], phencyclidine, barbiturates, benzodiazepines, cocaine, opioids) except if explained by use of allowed prescription medicines. Prospective subjects with a positive screen for tetrahydrocannabinol must agree to discontinue use upon study enrollment and for the duration of the study; 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; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply; Participants with facial pain other than TN.