A randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 85

Inclusion Criteria

• 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

Exclusion Criteria

• 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, gastrointestinal,
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 nonpharmacological 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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