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Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polyneuropathy; Peripheral Nerve Injury; Postherpetic Neuralgia

Intervention: Oxcarbazepine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Søren H. Sindrup

Official(s) and/or principal investigator(s):
Søren H Sindrup, MD, Principal Investigator, Affiliation: Department of Neurology, Odense University Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Total pain rated on numeric rating scale

Secondary outcome:

Response defined as at least 50% reduction in pain score

Neuropathic Pain Symptom Inventory

Patient Global Impression of Change

Rating of evoked pain

Sleep disturbance

Quality of life

Use of escape medication

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Danish Pain Research Center, Aarhus University Hospital, Aarhus 8000, Denmark

Department of Neurology, Odense University Hospital, Odense DK-5000, Denmark

Additional Information

Starting date: February 2011
Last updated: May 2, 2014

Page last updated: August 23, 2015

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