Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy (NCT01561027) | Clinical Trial Compass
CompletedPhase 2
Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
Czechia, Denmark82 participantsStarted 2011-04-30
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Key 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
* 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 1.
* Average baseline daily pain score for neuropathic pain due to LSR on the 11-point numerical rating scale of 4 or greater.
Key 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 …
What they're measuring
1
Change in Average Daily Neuropathic Pain Score from Baseline