Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

Søren H. Sindrup117 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

117

Conditions

Polyneuropathy Peripheral Nerve Injury Postherpetic Neuralgia

Interventions

OxcarbazepineDRUG

Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, Denmark

Department of Neurology, Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Total pain rated on numeric rating scale

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.

Time frame: Measurements from week 6 of treatment period

Secondary Outcomes

Response defined as at least 50% reduction in pain score

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

Time frame: Week 6 of each treatment period vs. baseline

Neuropathic Pain Symptom Inventory

Different pain dimensions as rated by Neuropathic Pain Symptom Inventory

Time frame: Week 6 of each treatment period

Patient Global Impression of Change

Time frame: Week 6 of each treatment period

Rating of evoked pain

Rating on numeric rating scales of pain induced by stimulation with cold rollers, stiff von Frey hain and dynamic touch with rubber sponge

Time frame: Week 6 of each treatment period

Sleep disturbance

Numeric rating scale ratings of pain induced sleep disturbance, median value of ratings from week 6 of each treatment period

Time frame: Week 6 of each treatment period

Quality of life

Data from ClinicalTrials.gov

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