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| Name | Class |
|---|---|
| Danish Pain Research Center | OTHER |
| Innovative Medicines Initiative | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxcarbazepine | Experimental | 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. |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren H Sindrup, MD | Department of Neurology, Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Pain Research Center, Aarhus University Hospital | Aarhus | 8000 | Denmark | |||
| Department of Neurology, Odense University Hospital |
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| ID | Term |
|---|---|
| D011115 | Polyneuropathies |
| D059348 | Peripheral Nerve Injuries |
| D051474 | Neuralgia, Postherpetic |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Neuropathic Pain Symptom Inventory |
Different pain dimensions as rated by Neuropathic Pain Symptom Inventory |
| Week 6 of each treatment period |
| Patient Global Impression of Change | Week 6 of each treatment period |
| 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 |
| 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 |
| Quality of life | Rating of quality of life with numeric rating scale | Week 6 of each treatment period |
| Use of escape medication | Number of paracetamol 500 mg used during the last week of each treamtent period | Week 6 of each treatment period |
| Odense |
| DK-5000 |
| Denmark |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |