Efficacy and Safety of BIIB074 in Participants with Trigeminal Neuralgia

A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Subjects With Trigeminal Neuralgia - 802NP301-BIIB074 in Participants with Trigeminal Neuralgia

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001449-16-GB

Enrollment

250

Registered

2017-01-03

Start date

2017-03-02

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia MedDRA version: 20.0 Level: PT Classification code 10044652 Term: Trigeminal neuralgia System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Vixotrigine Product Code: BIIB074 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Vixotrigine CAS Number: 934240-31-0 Current Sponsor code: BIIB074 Other descriptive name: C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - A diagnosis of TN for at least 3 months based on 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. NOTE: Other protocol defined Inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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. NOTE: Other protocol defined Exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by subjects with TN. The primary objective of the LTE phase of the study is to evaluate the long-term safety and tolerability of BIIB074 in subjects with TN.;Secondary Objective: Secondary objectives include the following: - To investigate the safety and tolerability of BIIB074 in subjects with TN. - To evaluate the population PK of BIIB074. The secondary objective of the LTE is to investigate the maintenance of effect during Long-term treatment with BIIB074 in subjects with TN.;Primary end point(s): The primary endpoint is the proportion of subjects classified as responders at Week 12 of the double-blind period. A participant who meets all of the following criteria will be classified as a responder: ? (1) Has a reduction of =30% in mean pain score compared with baseline ? (2) Has not discontinued randomized treatment before the end of Week 12 of the double-blind period ? (3) Has not taken prohibited pain medication before the end of Week 12 of the double-blind period The primary endpoint of LTE phase is the number of participants experiencing AEs and SAEs during the LTE from Baseline up to week 52.;Timepoint(s) of evaluation of this end point: The primary endpoint is the proportion of subjects classified as responders at Week 12 of the double-blind period. The primary endpoint of LTE phase is the number of participants experiencing AEs and SAEs during the LTE from Baseline up to Week 52.	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by subjects with TN. The primary objective of the LTE phase of the study is to evaluate the long-term safety and tolerability of BIIB074 in subjects with TN.;Secondary Objective: Secondary objectives include the following: - To investigate the safety and tolerability of BIIB074 in subjects with TN. - To evaluate the population PK of BIIB074. The secondary objective of the LTE is to investigate the maintenance of effect during Long-term treatment with BIIB074 in subjects with TN.;Primary end point(s): The primary endpoint is the proportion of subjects classified as responders at Week 12 of the double-blind period. A participant who meets all of the following criteria will be classified as a responder: ? (1) Has a reduction of =30% in mean pain score compared with baseline ? (2) Has not discontinued randomized treatment before the end of Week 12 of the double-blind period ? (3) Has not taken prohibited pain medication before the end of Week 12 of the double-blind period The primary endpoint of LTE phase is the number of participants experiencing AEs and SAEs during the LTE from Baseline up to week 52.;Timepoint(s) of evaluation of this end point: The primary endpoint is the proportion of subjects classified as responders at Week 12 of the double-blind period. The primary endpoint of LTE phase is the number of participants experiencing AEs and SAEs during the LTE from Baseline up to Week 52.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Week 12 and Week 52 for LTE phase endpoints;Secondary end point(s): •To investigate the safety and tolerability of BIIB074 in subjects with TN The endpoint that relates to this objective is the incidence of adverse events (AEs) and serious adverse events (SAEs) during the double blind period. •To evaluate the population pharmacokinetics of BIIB074 The endpoints that relate to this objective include area under the concentration time curve and maximum observed concentration at steady state. The secondary endpoints of LTE phase include the following: - Proportion of subjects with a response based on a =30% reduction in mean pain score during 4-week periods beginning on Day 1 through Week 52 of the LTE compared with baseline (run-in) - Change from baseline in mean pain score during 4-week periods beginning on Day 1 through Week 52 of the LTE - Change from baseline in mean worst pain score during 4-week periods beginning on Day 1 through Week 52 of the LTE - Proportion of subjects with a response based on a =50% reduction in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 52 of the LTE compared with baseline (run-in) - Change from baseline in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 52 of the LTE - Proportion of subjects with a PGIC response of “much improved” or “very much improved” by visit during the LTE - Change from baseline in the PENN-FPS-R score by visit during the LTE - Change from baseline in the EQ-5D-5L score by visit during the LTE - Change from baseline in the WPAI: Neuropathic Pain (V2.0) score by visit during the LTE	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Week 12 and Week 52 for LTE phase endpoints;Secondary end point(s): •To investigate the safety and tolerability of BIIB074 in subjects with TN The endpoint that relates to this objective is the incidence of adverse events (AEs) and serious adverse events (SAEs) during the double blind period. •To evaluate the population pharmacokinetics of BIIB074 The endpoints that relate to this objective include area under the concentration time curve and maximum observed concentration at steady state. The secondary endpoints of LTE phase include the following: - Proportion of subjects with a response based on a =30% reduction in mean pain score during 4-week periods beginning on Day 1 through Week 52 of the LTE compared with baseline (run-in) - Change from baseline in mean pain score during 4-week periods beginning on Day 1 through Week 52 of the LTE - Change from baseline in mean worst pain score during 4-week periods beginning on Day 1 through Week 52 of the LTE - Proportion of subjects with a response based on a =50% reduction in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 52 of the LTE compared with baseline (run-in) - Change from baseline in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 52 of the LTE - Proportion of subjects with a PGIC response of “much improved” or “very much improved” by visit during the LTE - Change from baseline in the PENN-FPS-R score by visit during the LTE - Change from baseline in the EQ-5D-5L score by visit during the LTE - Change from baseline in the WPAI: Neuropathic Pain (V2.0) score by visit during the LTE

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Countries

Argentina, Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Korea, Republic of, Russian Federation, Serbia, Slovakia, Switzerland, United Kingdom

Contacts

Public Contact802NP301 Clinical Trial Team

Biogen Idec Research Limited

clinicaltrials@biogen.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026