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

This study has been completed.
Sponsor:
Collaborators:
Danish Pain Research Center
Innovative Medicines Initiative
Information provided by (Responsible Party):
Søren H. Sindrup, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01302275
First received: February 23, 2011
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Polyneuropathy
Peripheral Nerve Injury
Postherpetic Neuralgia
Drug: Oxcarbazepine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain: Predictors of Response - a Randomised, Double-blind, Placebo-controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Total pain rated on numeric rating scale [ Time Frame: Measurements from week 6 of treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 6 of each treatment period vs. baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]
    Different pain dimensions as rated by Neuropathic Pain Symptom Inventory

  • Patient Global Impression of Change [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]
  • Rating of evoked pain [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]
    Numeric rating scale ratings of pain induced sleep disturbance, median value of ratings from week 6 of each treatment period

  • Quality of life [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]
    Rating of quality of life with numeric rating scale

  • Use of escape medication [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]
    Number of paracetamol 500 mg used during the last week of each treamtent period


Enrollment: 117
Study Start Date: February 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Trileptal
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 Name: Trileptal

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302275

Locations
Denmark
Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Department of Neurology, Odense University Hospital
Odense, Denmark, DK-5000
Sponsors and Collaborators
Søren H. Sindrup
Danish Pain Research Center
Innovative Medicines Initiative
Investigators
Principal Investigator: Søren H Sindrup, MD Department of Neurology, Odense University Hospital
  More Information

No publications provided

Responsible Party: Søren H. Sindrup, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01302275     History of Changes
Other Study ID Numbers: IMIOXC
Study First Received: February 23, 2011
Last Updated: May 2, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
neuropathic pain
oxcarbazepine
pain mechanism

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Polyneuropathies
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 23, 2014