NCT03941834终止2 期
BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuralgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 65
- 试验地点
- 19
- 主要终点
- Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of BHV3000 compared to placebo for subjects with treatment refractory Trigeminal Neuralgia as measured by a 2-point or greater reduction in the average Numeric Pain Rating Scale between the two-week treatment phases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects with a clinical diagnosis of typical or atypical classical trigeminal neuralgia based on the International Classification of Headache Disorders, 3rd edition, beta version.
- •Trigeminal neuralgia symptoms for a minimum of 8 weeks prior to randomization visit.
- •Neuroimaging to exclude another cause for the neuralgia, other than neurovascular compression.
排除标准
- •Subject has a structural lesion on neuroimaging, other than vascular compression of the trigeminal nerve or nerve root that would explain the neuralgia
- •Subject has a clinically evident neurologic deficit on neurologic exam of the cranial nerves
- •Subjects with a history of HIV disease
- •Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
- •Uncontrolled hypertension (high blood pressure) at screening
- •Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
- •Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease that causes malabsorption
- •Subject has a history or diagnosis of Gilbert's Syndrome or any other active hepatic or biliary disorder
- •The subject has a history or current evidence of any significant and/or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
- •History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit
- •Hematologic or solid malignancy diagnosis within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the screening visit in this study.
- •Hematologic or solid malignancy diagnosis within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the screening visit in this study.
- •Body mass index >33kg/m²
- •History of gallstones or cholecystectomy
研究组 & 干预措施
BHV3000
Active Comparator
干预措施: Rimegepant (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase
时间窗: DBT Phase: Baseline (before dose on Day 1), 2 Weeks Treatment
NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their average pain level over a 24-hour period on NPRS. Pain score was the average of the daily 11-point NPRS recorded within each period. Average of pain score on NPRS according to treatment received in first or second treatment period of DBT phase are used for evaluation of the outcome measure.
次要结局
- Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase(DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks))
- Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase(DBT Phase: Baseline, 2 Weeks Treatment)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: DBT Phase(DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks))
- Change From Baseline in Penn Facial Pain Scale-Revised (Penn-FPS-R) Total Score at 2 Week Treatment Phase: DBT Phase(DBT Phase: Baseline, 2 Weeks Treatment)
- Number of Participants With Clinically Significant Laboratory Abnormalities: DBT Phase(DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks))
- Change From Baseline in Pain Disability Index Total Score at 2 Week Treatment Phase: DBT Phase(DBT Phase: Baseline, 2 Weeks Treatment)
- Patient Global Impression of Change Scale (PGI-C) Score at 2 Week Treatment Phase: DBT Phase(DBT Phase: Baseline, 2 Weeks Treatment)
- Change From Baseline in Average Worst Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase(DBT Phase: Baseline, 2 Weeks Treatment)
- Percentage of Participants With >= 2 Point Reduction From Baseline in Average Daily Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase(DBT Phase: Baseline, 2 Weeks Treatment)
研究者
研究点 (19)
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