EUCTR2010-023962-39-CZ进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Male subjects must 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.
- •Average QTcB or QTcF < 450 msec; or QTc < 480msec in subjects with Bundle Branch Block at screening.
- •AST and ALT < 2xULN; alkaline phosphatase and bilirubin = 1.5xULN.
- •Approved concomitant medications must have been stable for at least 4 weeks prior to day 1.
- •Average baseline daily pain score for neuropathic pain due to LSR on the 11-point numerical rating scale of 4
- •or greater.
- •France only: patients must be affiliated to a health social security system.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 1.
- •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 CNV1014802.
- •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.
- •Subject who, in the clinical judgement of the investigator, may be malingering or be motivated by secondary gain from participation in the study.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
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