Trigeminal Neuralgia MedDRA version: 20.0 Level: PT Classification code 10044652 Term: Trigeminal neuralgia System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Biogen Idec Research Limited
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. - 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 ofcarbamazepine 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). 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 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. -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 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.;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 104. ;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 aresponder: (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 104. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The endpoints that relate to this objective are AUC and Cmax 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 104 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 104 of the LTE - Change from baseline in mean worst pain score during 4-week periods beginning on Day 1 through Week 104 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 104 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 104 of the LTE - Proportion of subjects with a PGIC response of "much improved" or "very muchimproved" 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 ;Timepoint(s) of evaluation of this end point: The endpoints that relate to this objective are AUC and Cmax 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 104 compared with baseline (run-in) - Change from baseline in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 104 - Proportion of subjects with a PGIC response of "much improved" or "very muchimproved" by visit - Change from baseline in the PENN-FPS-R score by visit - Change from baseline in the EQ-5D-5L score by visit - Change from baseline in the WPAI: Neuropathic Pain (V2.0) score by | — |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Japan, Korea, Republic of, Russian Federation, Serbia, Slovakia, United Kingdom, United States
Contacts
Public Contact802NP301 Clinical Trial Team
Biogen Idec Research Limited
Outcome results
None listed