Overview

802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia

Status:
Not yet recruiting
Trial end date:
2026-08-21
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biogen
Criteria
Key Inclusion Criteria:

- 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).

Key Exclusion Criteria:

- 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.

- Participants with facial pain other than TN.

- 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.

- Positive pregnancy test result at Screening (women of childbearing potential only)

- Has donated blood or blood products within a 30-day period prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply