802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia

NCT ID: NCT03637387

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-09-29

Brief Summary

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.

Conditions

Trigeminal Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BIIB074

Administered orally three times daily (TID)

Group Type: EXPERIMENTAL

BIIB074

Intervention Type: DRUG

Administered as specified in the treatment arm

Placebo

Placebo matching BIIB074

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered as specified in the treatment arm.

Interventions

BIIB074

Administered as specified in the treatment arm

Intervention Type: DRUG

Placebo

Administered as specified in the treatment arm.

Intervention Type: DRUG

Eligibility Criteria

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.
• 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 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.
• 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.
• Known hypersensitivity to BIIB074 or components of the BIIB074 formulation or matching placebo.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Other Identifiers

2016-002473-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

802NP302

Identifier Type: -

Identifier Source: org_study_id