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

Active, not recruiting

• Conditions: europathic pain from lumbosacral radiculopathy; MedDRA version: 14.1Level: PTClassification code 10050219Term: Lumbar radiculopathySystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2010-023962-39-CZ
• Lead Sponsor: Convergence Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-07
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

• Status: Not 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, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of repeat oral dosing of CNV1014802 on neuropathic pain in subjects with lumbosacral radiculopathy.;Secondary Objective: To investigate the effects of repeat oral dosing of CNV1014802 on low back pain in subjects with lumbosacral radiculopathy in whom there is lower limb pain. <br><br>To investigate the effects of repeat oral dosing of CNV1014802 on function in subjects with pain from lumbosacral radiculopathy.<br><br>To investigate the safety and tolerability of CNV1014802 in subjects with lumbosacral radiculopathy.<br><br>To assess the pharmacokinetics of CNV1014802 <br><br>Exploratory objective: Pharmacokinetic-pharmacodynamic relationships, if data permit.<br>;Primary end point(s): 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).