NCT01561027已完成2 期
A Randomized, Double Blind, Cross-over Study to Evaluate the Safety and Efficacy of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change in Average Daily Neuropathic Pain Score from Baseline
研究概览
简要总结
The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.
详细描述
The study consists of two treatment periods of 22 days with randomized CNV1014802 350mg or placebo administered twice daily. In addition, single blind placebo will be administered during a two week run-in, a two week wash-out period between the two treatment periods, and a one week run-out phase.
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 18 and 65 years, with a diagnosis of neuropathic pain due to lumbosacral radiculopathy (LSR).
- •Female subjects must be of non-child bearing potential or agree to use an approved form of contraception
- •Body weight < 50 kg for men and < 45 kg for women.
- •Capable of giving written informed consent.
- •Approved concomitant medications must have been stable for at least 4 weeks prior to day
- •Average baseline daily pain score for neuropathic pain due to LSR on the 11-point numerical rating scale of 4 or greater.
排除标准
- •Subjects who are unable to reliably delineate or assess their own pain by anatomical location/distribution.
- •Subjects with lumbar canal stenosis in which the pain in the lower limbs occur solely on walking and not at rest.
- •Subjects with causes for their neuropathic pain other than LSR.
- •Subjects who have received nerve blocks and/or steroid injections for neuropathic pain within 4 weeks prior to day
- •Subjects who are indicated for surgical treatment of lumbosacral radiculopathy.
- •A positive pre-study drug screen.
- •A positive history of HIV.
- •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- •History of any liver disease within the last 6 months, with the exception of known Gilbert's disease.
- •History of excessive regular alcohol consumption within 6 months of the study.
- •Subjects with a history or risk of seizures or a history of epilepsy, head injury or related neurological disorders
- •Subjects with a history of uncontrolled or poorly controlled hypertension, with systolic BP frequently exceeding 160mmHg and/or diastolic BP frequently exceeding 100mmHg, or subjects who have BP greater than or equal to 160mmHg systolic and/or greater than or equal to 100mmHg diastolic at screening after repeated measurements
- •History or presence of significant cardiovascular, gastro-intestinal, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •Subjects with conditions known to affect cardiac conduction or a personal or familial history of Brugada syndrome
- •Pregnant females or lactating females.
- •History or presence of any clinically significant abnormality in vital signs / ECG / laboratory tests or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety.
- •History of suicidal ideation and/or suicide attempts or clinical evidence of recent major depression.
- •Subjects who are unable to maintain their same medications for the treatment of neuropathic pain at a stable dose during the study.
- •Unable to refrain from excessive use of sedatives.
- •Unable to comply with the prohibited concomitant medication restrictions as detailed in the protocol. This includes but is not limited to sodium channel blockers or drugs that adversely interact with a monoamine oxidase-B inhibitor: MAOI's, antidepressants, opioids and sympathomimetic agents.
- •Unable to stop and remain abstained from non-pharmacological treatments for their neuropathic pain during the study.
- •History of hypersensitivity to CNV
- •The subject has participated in a clinical trial and has received an investigational product within 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to the start of this study.
- •Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- •Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- •Subject is mentally or legally incapacitated.
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply
研究组 & 干预措施
CNV1014802
Experimental
CNV1014802 350mg on prescription (BID) for 21 days
干预措施: CNV1014802 (Drug)
Placebo
Placebo Comparator
Placebo 350mg BID for 21 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Average Daily Neuropathic Pain Score from Baseline
时间窗: Three weeks
Change in average daily neuropathic pain score from baseline (average days 10-14) to week 3 based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=maximum pain imaginable). Subjects should specifically rate the pain intensity for the neuropathic pain associated with lumbosacral radiculopathy and not pain from other concomitant causes
次要结局
- Numerical Pain Rating Scale(3 weeks)
- Responder Rate(3 weeks)
- Galer Neuropathic Pain Scale(3 weeks)
- Oswestry Disability Index(3 weeks)
- CGIC(3 weeks)
- PGIC(3 weeks)
研究者
研究点 (1)
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