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Completed

NCT Number: NCT01302275

Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

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.

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Key information

Conditions

Polyneuropathy Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nerve Injuries Peripheral Nerve Injury Peripheral Nervous System Diseases Polyneuropathies Postherpetic Neuralgia Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxcarbazepine

Drug

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

Primary outcomes

  1. Total pain rated on numeric rating scale

    Time frame: Measurements from week 6 of treatment period

    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 outcomes

  1. Response defined as at least 50% reduction in pain score

    Time frame: Week 6 of each treatment period vs. baseline

    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

  2. Neuropathic Pain Symptom Inventory

    Time frame: Week 6 of each treatment period

    Different pain dimensions as rated by Neuropathic Pain Symptom Inventory

  3. Patient Global Impression of Change

    Time frame: Week 6 of each treatment period

  4. Rating of evoked pain

    Time frame: Week 6 of each treatment period

    Rating on numeric rating scales of pain induced by stimulation with cold rollers, stiff von Frey hain and dynamic touch with rubber sponge

  5. Sleep disturbance

    Time frame: Week 6 of each treatment period

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

  6. Quality of life

    Time frame: Week 6 of each treatment period

    Rating of quality of life with numeric rating scale

  7. Use of escape medication

    Time frame: Week 6 of each treatment period

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

Sponsors and collaborators

Lead sponsor

Søren H. Sindrup

Other

Collaborators

  • Danish Pain Research Center
  • Innovative Medicines Initiative

Registry information

Official study title

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

Acronym: IMIOXC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2011
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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