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 in Subjects With Trigeminal Neuralgia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002473-35-CZ

Enrollment

250

Registered

2016-12-22

Start date

2017-05-19

Completion date

Unknown

Last updated

2023-08-21

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: BIIB074 Product Code: BIIB074 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: N/A CAS Number: 934240-31-0 Current Sponsor code: BIIB074 Other descriptive name: CNV1014802 Co

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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

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.;Primary end point(s): 1. Time from randomization to loss of therapeutic response (LOTR). 2. Change from baseline to Week 12 of the double-blind period in weekly mean ADP. 3. Proportion of subjects with a response in number of paroxysms at Week 12 of the double-blind period. 4. Proportion of subjects with a PGIC response at Week 12 of the doubleblind period. 5. Change from baseline to Week 12 of the double-blind period in the Penn Facial Pain Scale-Revised (PENN-FPS-R) score. The primary endpoint of LTE phase is assessment of the following safety parameters: - Incidence of AEs and SAEs - Laboratory safety tests - Vital signs - 12-lead ECG parameters C-SSRS;Timepoint(s) of evaluation of this end point: 1. Time from randomization to loss of therapeutic response (LOTR). 2. Change from baseline to Week 12 of the double-blind period in weekly mean ADP. 3. Proportion of subjects with a response in number of paroxysms at Week 12 of the double-blind period. 4. Proportion of subjects with a PGIC response at Week 12 of the doubleblind period. 5. Change from baseline to Week 12 of the double-blind period in the Penn Facial Pain Scale-Revised (PENN-FPS-R) score. The primary endpoint of LTE phase is assessment of the following safety parameters: - Incidence of AEs and SAEs - Laboratory safety tests - Vital signs - 12-lead ECG parameters - C-SSRS	—

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.;Primary end point(s): 1. Time from randomization to loss of therapeutic response (LOTR). 2. Change from baseline to Week 12 of the double-blind period in weekly mean ADP. 3. Proportion of subjects with a response in number of paroxysms at Week 12 of the double-blind period. 4. Proportion of subjects with a PGIC response at Week 12 of the doubleblind period. 5. Change from baseline to Week 12 of the double-blind period in the Penn Facial Pain Scale-Revised (PENN-FPS-R) score. The primary endpoint of LTE phase is assessment of the following safety parameters: - Incidence of AEs and SAEs - Laboratory safety tests - Vital signs - 12-lead ECG parameters C-SSRS;Timepoint(s) of evaluation of this end point: 1. Time from randomization to loss of therapeutic response (LOTR). 2. Change from baseline to Week 12 of the double-blind period in weekly mean ADP. 3. Proportion of subjects with a response in number of paroxysms at Week 12 of the double-blind period. 4. Proportion of subjects with a PGIC response at Week 12 of the doubleblind period. 5. Change from baseline to Week 12 of the double-blind period in the Penn Facial Pain Scale-Revised (PENN-FPS-R) score. The primary endpoint of LTE phase is assessment of the following safety parameters: - Incidence of AEs and SAEs - Laboratory safety tests - Vital signs - 12-lead ECG parameters - C-SSRS

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Secondary

Measure	Time frame
Secondary end point(s): The endpoints that relate to this objective are as follows: - AEs and SAEs - Vital signs - ECG parameters - Laboratory safety tests - C-SSRS The secondary endpoints of LTE phase include the following: - Proportion of subjects with a response in ADP based on =30% reduction in weekly mean ADP at each week of the LTE compared with baseline (run-in) - Change from baseline in weekly mean ADP - Proportion of subjects with PGIC response of "much improved" or "very much improved" - Change from baseline in the PENN-FPS-R score;Timepoint(s) of evaluation of this end point: The endpoints that relate to this objective are as follows: - AEs and SAEs - Vital signs - ECG parameters - Laboratory safety tests - C-SSRS The secondary endpoints of LTE phase include the following: - Proportion of subjects with a response in ADP based on =30% reduction in weekly mean ADP at each week of the LTE compared with baseline (run-in) - Change from baseline in weekly mean ADP - Proportion of subjects with PGIC response of "much improved" or "very much improved" - Change from baseline in the PENN-FPS-R score	—

Measure

Time frame

Secondary end point(s): The endpoints that relate to this objective are as follows: - AEs and SAEs - Vital signs - ECG parameters - Laboratory safety tests - C-SSRS The secondary endpoints of LTE phase include the following: - Proportion of subjects with a response in ADP based on =30% reduction in weekly mean ADP at each week of the LTE compared with baseline (run-in) - Change from baseline in weekly mean ADP - Proportion of subjects with PGIC response of "much improved" or "very much improved" - Change from baseline in the PENN-FPS-R score;Timepoint(s) of evaluation of this end point: The endpoints that relate to this objective are as follows: - AEs and SAEs - Vital signs - ECG parameters - Laboratory safety tests - C-SSRS The secondary endpoints of LTE phase include the following: - Proportion of subjects with a response in ADP based on =30% reduction in weekly mean ADP at each week of the LTE compared with baseline (run-in) - Change from baseline in weekly mean ADP - Proportion of subjects with PGIC response of "much improved" or "very much improved" - Change from baseline in the PENN-FPS-R score

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Countries

Australia, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Switzerland, Taiwan, United States

Contacts

Public Contact802NP302 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