Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

Postherpetic Neuralgia Clinical Trial

— IMIOXC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302275
• Other study ID #: IMIOXC
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2011
• Last updated: May 2, 2014
• Start date: February 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Peripheral Nerve Injuries
• Peripheral Nerve Injury
• Polyneuropathies
• Polyneuropathy
• Postherpetic Neuralgia

Intervention

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

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University Hospital	Aarhus
Denmark	Department of Neurology, Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Søren H. Sindrup	Danish Pain Research Center, Innovative Medicines Initiative

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Neuropathic Pain Symptom Inventory	Different pain dimensions as rated by Neuropathic Pain Symptom Inventory	Week 6 of each treatment period	No
Secondary	Patient Global Impression of Change		Week 6 of each treatment period	No
Secondary	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	No
Secondary	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	No
Secondary	Quality of life	Rating of quality of life with numeric rating scale	Week 6 of each treatment period	No
Secondary	Use of escape medication	Number of paracetamol 500 mg used during the last week of each treamtent period	Week 6 of each treatment period	No