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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 May 2023
• Main ID: NCT03070132
• Date of registration: 28/02/2017
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: 802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia SURGE-1
• Scientific title: A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia
• Date of first enrolment: April 19, 2023
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03070132
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Trigeminal Neuralgia

Intervention(s)

Drug: BIIB074

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Classified as Responders at Week 12 of the Double-Blind Period [Time Frame: Week 12]

Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Long Term Extension (LTE) Period [Time Frame: Baseline up to Week 52]

Secondary Outcome(s)

Change From Baseline in Mean Number of Paroxysms During Long Term Extension (LTE) Period [Time Frame: Baseline, Week 1 through Week 52]

Percentage of Participants with >=50% Reduction From Baseline in Mean Number of Paroxysms During Long Term Extension (LTE) Period [Time Frame: Week 1 through Week 52]

Area Under the Plasma Concentration- Time Curve at Steady State (AUC,ss) [Time Frame: Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred)]

Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Pain Score at Week 12 [Time Frame: Week 12]

Change From Baseline in the EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Score by Visit During the Long Term Extension (LTE) Period [Time Frame: Baseline, Day 1, Week 4, 8, every 12 weeks up to Week 52]

Change From Baseline in the Penn Facial Pain Scale-Revised (PENN-FPS-R) Score by Visit During the Long Term Extension (LTE) Period [Time Frame: Baseline, Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52]

Percentage of Participants with >=30% Reduction From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period [Time Frame: Week 1 through Week 52]

Maximum Observed Plasma Concentration at Steady State (Cmax,ss) [Time Frame: Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred)]

Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Neuropathic Pain (V2.0) Score by Visit During the Long Term Extension (LTE) Period [Time Frame: Baseline, Day 1, Week 4, 8, every 12 weeks up to Week 52]

Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During Double Blind Period [Time Frame: Up to Week 14 of Double blind period]

Percentage of Participants With a PGIC Response of "Much Improved or "Very Much Improved" by Visit During the Long Term Extension (LTE) Period [Time Frame: Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52]

Change From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period [Time Frame: Baseline, Week 1 through Week 52]

Change From Baseline In Mean Worst Pain Score During the Long Term Extension (LTE) Period [Time Frame: Baseline, Week 1 through Week 52]

Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Number of Paroxysms at Week 12 [Time Frame: Week 12]

Percentage of Participants Classified as Responders Achieving Patient Global Impression of Change (PGIC) Response at Week 12 of the Double- Blind Period [Time Frame: Week 12]

Secondary ID(s)

2016-001449-16

802NP301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors