Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain (IMIOXC)

Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain: Predictors of Response - a Randomised, Double-blind, Placebo-controlled Clinical Trial

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 Overview

• Status: Completed
• Conditions: Postherpetic Neuralgia; Peripheral Nerve Injury; Polyneuropathy
• Intervention / Treatment: Drug: Oxcarbazepine

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Danish Pain Research Center, Aarhus University Hospital
  • Odense, Denmark, DK-5000
    • Department of Neurology, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Oxcarbazepine; Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day; Other Names: Trileptal
Experimental: 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.	Drug: Oxcarbazepine; Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day; Other Names: Trileptal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurements from week 6 of treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 6 of each treatment period vs. baseline
Neuropathic Pain Symptom Inventory	Different pain dimensions as rated by Neuropathic Pain Symptom Inventory	Week 6 of each treatment period
Patient Global Impression of Change		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	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	Week 6 of each treatment period
Quality of life	Rating of quality of life with numeric rating scale	Week 6 of each treatment period
Use of escape medication	Number of paracetamol 500 mg used during the last week of each treamtent period	Week 6 of each treatment period

Collaborators and Investigators

• Sponsor: Søren H. Sindrup
• Collaborators: Danish Pain Research Center; Innovative Medicines Initiative
• Investigators: Principal Investigator: Søren H Sindrup, MD, Department of Neurology, Odense University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): May 5, 2014
• Last Update Submitted That Met QC Criteria: May 2, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: neuropathic pain; oxcarbazepine; pain mechanism
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Neuralgia; Polyneuropathies; Neuralgia, Postherpetic; Peripheral Nerve Injuries; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Oxcarbazepine
• Other Study ID Numbers: IMIOXC