EUCTR2010-023962-39-CZ
Active, not recruiting
Not Applicable
A randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy
Conditionseuropathic pain from lumbosacral radiculopathyMedDRA version: 14.1Level: PTClassification code 10050219Term: Lumbar radiculopathySystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- europathic pain from lumbosacral radiculopathy
- Sponsor
- Convergence Pharmaceuticals Ltd
- Enrollment
- 85
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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