Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT03070132
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03070132
Study Brief:
Protocol Section:
NCT03070132