A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Biogen
- 主要终点
- Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Long Term Extension (LTE) Period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
BIIB074
Administered orally three times daily (TID)
干预措施: BIIB074 (Drug)
Placebo
Placebo matching BIIB074
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Long Term Extension (LTE) Period
时间窗: Baseline up to Week 52 of the LTE
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect.
Percentage of Participants Classified as Responders at Week 12 of the Double- Blind Period
时间窗: Week 12
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.
次要结局
- Area Under the Plasma Concentration- Time Curve at Steady State (AUC,ss)(Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred))
- Change From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period(Baseline, Week 1 through Week 52)
- Percentage of Participants With a PGIC Response of "Much Improved or "Very Much Improved" by Visit During the Long Term Extension (LTE) Period(Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52)
- Change From Baseline in the WPAI Neuropathic Pain (V2.0) Score by Visit During the Long Term Extension (LTE) Period(Baseline, Day 1, Week 4, 8, every 12 weeks up to Week 52)
- Percentage of Participants Classified as Responders Achieving Patient Global Impression of Change (PGIC) Response at Week 12 of the Double-Blind Period(Week 12)
- Maximum Observed Plasma Concentration at Steady State (Cmax,ss)(Day 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, premature treatment discontinuation (if occurred))
- Percentage of Participants with >=30% Reduction From Baseline in Mean Pain Score During the Long Term Extension (LTE) Period(Week 1 through Week 52)
- Change From Baseline in Mean Worst Pain Score During the Long Term Extension (LTE) Period(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(Week 12)
- Percentage of Participants Classified as Responders Achieving >=50 Percent Reduction From Baseline Mean Pain Score at Week 12(Week 12)
- Percentage of Participants with >=50% Reduction From Baseline in Mean Number of Paroxysms During Long Term Extension (LTE) Period(Week 1 through Week 52)
- Change From Baseline in the EQ-5D-5L Score by Visit During the Long Term Extension (LTE) Period(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 the Double Blind Period(Up to Week 14 of Double blind period)
- Change From Baseline in the PENN-FPS-R Score by Visit During the Long Term Extension (LTE) Period(Baseline, Day 1, Week 2, 4, 6, 8, every 12 weeks up to Week 52)
- Change From Baseline in Mean Number of Paroxysms During Long Term Extension (LTE) Period(Baseline, Week 1 through Week 52)