802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia (SURGE-1)

Biogen

Status and phase: Withdrawn; Phase 3

Conditions: Trigeminal Neuralgia

Treatments: Drug: BIIB074; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03070132

2016-001449-16 (EudraCT Number)

802NP301

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

BIIB074

Experimental group

Description:

Optimized oral dose three times daily (TID)

Treatment:

Drug: BIIB074

Placebo

Experimental group

Description:

Administered orally TID

Treatment:

Drug: Placebo