Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

Phase 4

Completed

• Conditions: Polyneuropathy; Peripheral Nerve Injury; Postherpetic Neuralgia
• Interventions: Drug: Oxcarbazepine

• Registration Number: NCT01302275
• Lead Sponsor: Søren H. Sindrup

Brief Summary

The purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-02
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• age > 18 years old
• definite or probable neuropathic pain
• diagnosis of polyneuropathy, postherpetic neuralgia or peripheral nerve inju
• pain duration > 3 months
• pain rating at baseline >= 4 point NRS
• Informed consent

Exclusion Criteria

• other non-neuropathic pain condition
• allergy to oxcarbazepine
• renal or hepatic impairment
• epilepsy
• depression and other serious psychiatric disorders
• serious medical condition
• previous treatment for neuropathic that cannot be stopped
• pregnancy
• patients expected not to be able to comply with study protocol
• treatment with anticonvulsants, antidepressant or opioids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
oxcarbazepine	Oxcarbazepine	Oxcarbazepine is gradually increased during 21 days from 300 mg x 1 daily to 2400 mg, and kept on that dose ( 2400 mg) for three weeks.
placebo	Oxcarbazepine	-

Primary Outcome Measures

Name	Time	Method
Total pain rated on numeric rating scale	Measurements from week 6 of treatment period	Pain is rated daily on 0-10 point numeric rating scales. From the daily ratings from week 6 of each treatment period a median value is determined and used for data analysis. The analysis will compare scores between treatments (oxcabazepine vs placebo) and treatment effects (placebo-oxcarbazepine) between groups irritable nociceptor vs non-irritable nociceptors and some other subgroups.

Secondary Outcome Measures

Name	Time	Method
Response defined as at least 50% reduction in pain score	Week 6 of each treatment period vs. baseline	Response defined as 50% reduction in pain score (median value week 6 of treatment period compared to median value during baseline period). Repsonse rates for each treatment and each phenotype will be calculated
Neuropathic Pain Symptom Inventory	Week 6 of each treatment period	Different pain dimensions as rated by Neuropathic Pain Symptom Inventory
Patient Global Impression of Change	Week 6 of each treatment period
Rating of evoked pain	Week 6 of each treatment period	Rating on numeric rating scales of pain induced by stimulation with cold rollers, stiff von Frey hain and dynamic touch with rubber sponge
Sleep disturbance	Week 6 of each treatment period	Numeric rating scale ratings of pain induced sleep disturbance, median value of ratings from week 6 of each treatment period
Quality of life	Week 6 of each treatment period	Rating of quality of life with numeric rating scale
Use of escape medication	Week 6 of each treatment period	Number of paracetamol 500 mg used during the last week of each treamtent period

Trial Locations

Locations (2)

Danish Pain Research Center, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Neurology, Odense University Hospital; 🇩🇰 Odense, Denmark