NCT07262268Enrolling By Invitation1 期
A Phase 1b, Double-Blind, Crossover Study of BHV-7000 in Patients With Inherited Erythromelalgia (IEM) With NaV1.7 Gain of Function Mutations
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mean of the daily average maximum pain intensity scores collected every 2 hours.
研究概览
简要总结
The purpose of this study is to test the potential benefits of BHV-7000 in reducing chronic pain in participants with IEM with a previously demonstrated gain of function mutation in the SCN9A gene.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women between 18 to 75 years of age, inclusive, at time of consent with a diagnosis of inherited erythromelalgia with a previously characterized gain of function NaV1.7 mutation resulting in chronic pain.
- •Absence of concomitant mutation resulting in Kv7.2/7.3 gain of function.
- •Ability and willingness to adhere to the study procedures and complete accurate pain diaries
- •Stable background analgesic regimen for at least 30 days before screening and willingness to maintain the same analgesic regimen during the study period.
排除标准
- •Any clinically significant laboratory abnormalities or clinically significant abnormalities on screening physical examination, vital signs, or ECG that, in the judgment of the principal investigator, indicates a medical problem that would preclude study participation.
- •Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BHV-7000
Experimental
干预措施: BHV-7000 (Drug)
结局指标
主要结局
Mean of the daily average maximum pain intensity scores collected every 2 hours.
时间窗: The last 3 weeks of each 4-week crossover treatment period
Participants will be asked to record peak (worst) pain experienced in the previous 2 hours using an 11-point Likert scale (0-10) where 0=no pain and 10=worst possible pain
次要结局
- The average weekly frequency of pain attacks on treatment vs. placebo(The last 3 weeks of each 4-week crossover treatment period)
- The average duration of pain attacks on treatment vs. placebo(The last 3 weeks of each 4-week crossover treatment period)
- The average peak severity of pain attacks on treatment vs. placebo(The last 3 weeks of each 4-week crossover treatment period)
- Safety and tolerability by reporting the frequency of unique participants with SAEs, severe AEs, AEs leading to discontinuation, deaths, and Grade 3-4 (CTCAE/DAIDS) laboratory abnormalities.(Up to 16 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
BHV-7000 Acute Treatment of Bipolar ManiaBipolar DisorderNCT06419582Biohaven Therapeutics Ltd.274
已完成
2 期
Efficacy and Safety Study of BHV-7000 Monotherapy in Major DepressionMajor Depressive DisorderNCT06419608Biohaven Therapeutics Ltd.336
终止
2 期
Efficacy and Safety Study of BIIB074 in Participants With Small Fiber NeuropathySmall Fiber NeuropathyDiabetes MellitusNCT03339336Biogen265
终止
2 期
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic SeizuresGeneralized EpilepsyNCT06425159Biohaven Therapeutics Ltd.27
撤回
3 期
802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal NeuralgiaTrigeminal NeuralgiaNCT03070132Biogen