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

Primary Purpose

Polyneuropathy, Peripheral Nerve Injury, Postherpetic Neuralgia

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Oxcarbazepine

About this trial

This is an interventional treatment trial for Polyneuropathy focused on measuring neuropathic pain, oxcarbazepine, pain mechanism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Danish Pain Research Center, Aarhus University Hospital
Department of Neurology, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oxcarbazepine

placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Neuropathic Pain Symptom Inventory

Different pain dimensions as rated by Neuropathic Pain Symptom Inventory

Patient Global Impression of Change

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

Sleep disturbance

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

Quality of life

Rating of quality of life with numeric rating scale

Use of escape medication

Number of paracetamol 500 mg used during the last week of each treamtent period

Full Information

NCT ID

NCT01302275

First Posted

February 23, 2011

Last Updated

May 2, 2014

Sponsor

Søren H. Sindrup

Collaborators

Danish Pain Research Center, Innovative Medicines Initiative

1. Study Identification

Unique Protocol Identification Number

NCT01302275

Brief Title

Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

Acronym

IMIOXC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Søren H. Sindrup

Collaborators

Danish Pain Research Center, Innovative Medicines Initiative

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polyneuropathy, Peripheral Nerve Injury, Postherpetic Neuralgia

Keywords

neuropathic pain, oxcarbazepine, pain mechanism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oxcarbazepine

Arm Type

Experimental

Arm Description

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.

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Oxcarbazepine

Other Intervention Name(s)

Trileptal

Intervention Description

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

Primary Outcome Measure Information:

Title

Total pain rated on numeric rating scale

Description

Time Frame

Measurements from week 6 of treatment period

Secondary Outcome Measure Information:

Title

Response defined as at least 50% reduction in pain score

Description

Time Frame

Week 6 of each treatment period vs. baseline

Title

Neuropathic Pain Symptom Inventory

Description

Different pain dimensions as rated by Neuropathic Pain Symptom Inventory

Time Frame