Oxcarbazepine for the treatment of chronic peripheral neuropathic pain: predictors of response - a randomised, double-blind, placebo-controlled clinical trial - Oxcarbazepin for treatment of peripheral neuropathic pain

Department of Neurology, Odense University Hospital0 个研究点开始时间: 2010年11月29日最近更新: 2015年2月16日

试验速览

暂无简介。

•125 patients aged 18 or more with peripheral neuropathic pain for at least 3 month with a pain intensity of at least 4 (0-10) due to polyneuropathy, postherpetic neuralgia or peripheral nerve injury (e.g. postsurgical).
•At baseline, patients undergo a quantitative sensory testing (QST) (defined in WP 4.3) and patients will be phenotyped with respect to quantitative sensory testing and subdivided into one group with pain suggested to be caused by irritable nociceptors (Nin), defined as preserved cold or warm sensation (detections thresholds within the 95% CI of the reference material and no relative abnormality) and hypersensitivity to touch, pinprick or thermal stimuli), the remainder without this phenotype. Thus, using the nomenclature from the German network, the Nin includes: L0G1, L0G1, L0G2, L0G3, L2G1, L2G2, L2G3 and Nnin all combinations with L1 and L3 and L0G0 and L2G0 (Maier et al. 2010).
•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) yes
•F.1.3.1 Number of subjects for this age range

•Exclusion criteria include pregnancy or lactation, allergy to oxcarbazepine, past history of hypersensitivity to carbamazepine or oxcarbazepine, renal or severe hepatic impairment epilepsy, depression and psychiatric disorders. Concomitant medication for neuropathic pain is not allowed but previous treatments for neuropathic pain are not a contraindication.

发起方

Department of Neurology, Odense University Hospital