Peripheral Nerve Injury, Polyneuropathy, Postherpetic Neuralgia
Conditions
Keywords
neuropathic pain, oxcarbazepine, pain mechanism
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.
Interventions
DRUGOxcarbazepine
Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day
Sponsors
Danish Pain Research Center
Innovative Medicines Initiative
Søren H. Sindrup
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total pain rated on numeric rating scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Symptom Inventory | Week 6 of each treatment period | Different pain dimensions as rated by Neuropathic Pain Symptom Inventory |
| Patient Global Impression of Change | Week 6 of each treatment period | — |
| Rating of evoked pain | 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 |
| Response defined as at least 50% reduction in pain score | 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 |
| Quality of life | Week 6 of each treatment period | Rating of quality of life with numeric rating scale |
| Use of escape medication | Week 6 of each treatment period | Number of paracetamol 500 mg used during the last week of each treamtent period |
| Sleep disturbance | 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 |
Countries
Denmark
Outcome results
None listed