Clinical trial NCT03637387: 802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia
Official title: A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Trigeminal Neuralgia
Keywords: TGN
TN
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.
* 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).

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.
* 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants Classified as Responders at Week 12 of the Double- Blind Period
timeFrame: Week 12
measure: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Long Term Extension (LTE) Period
timeFrame: Baseline up to Week 52 of the LTE
Secondary outcomes:
measure: Percentage of Participants Classified as Responders Achieving Patient Global Impression of Change (PGIC) Response at Week 12 of the Double-Blind Period
timeFrame: Week 12
measure: Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Number of Paroxysms at Week 12
timeFrame: Week 12
measure: Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Pain Score at Week 12
timeFrame: Week 12
measure: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Double Blind Period
timeFrame: Up to Week 14 of Double blind period
measure: Area Under the Plasma Concentration- Time Curve at Steady State (AUC,ss)
timeFrame: Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred)
measure: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
timeFrame: Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred)
measure: Percentage of Participants with >=30% Reduction From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period
timeFrame: Week 1 through Week 52
measure: Change From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period
timeFrame: Baseline, Week 1 through Week 52
measure: Change From Baseline in Mean Worst Pain Score During the Long Term Extension (LTE) Period
timeFrame: Baseline, Week 1 through Week 52
measure: Percentage of Participants with >=50% Reduction From Baseline in Mean Number of Paroxysms During Long Term Extension (LTE) Period
timeFrame: Week 1 through Week 52
measure: Change From Baseline in Mean Number of Paroxysms During Long Term Extension (LTE) Period
timeFrame: Baseline, Week 1 through Week 52
measure: Percentage of Participants With a PGIC Response of "Much Improved or "Very Much Improved" by Visit During the Long Term Extension (LTE) Period
timeFrame: Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52
measure: Change From Baseline in the PENN-FPS-R Score by Visit During the Long Term Extension (LTE) Period
timeFrame: Baseline, Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52
measure: Change From Baseline in the EQ-5D-5L Score by Visit During the Long Term Extension (LTE) Period
timeFrame: Baseline, Day 1, Week 4, 8, every 12 weeks up to Week 52
measure: Change From Baseline in the WPAI Neuropathic Pain (V2.0) Score by Visit During the Long Term Extension (LTE) Period
timeFrame: Baseline, Day 1, Week 4, 8, every 12 weeks up to Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: