Chronic peripheral neuropathic pain caused by polyneuropathy, postherpetic neuralgia and traumatic/surgical nerve injury. MedDRA version: 12.1 Level: LLT Classification code 10054095 Term: Neuropathic pain
Conditions
Interventions
Trade Name: Trileptal
Product Name: Trileptal
Pharmaceutical Form: Capsule*
INN or Proposed INN: OXCARBAZEPINE
CAS Number: 28721-07-5
Pharmaceutical form of the placebo: Capsule*
Route of administrati
Sponsors
Department of Neurology, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 125 patients aged 18 or more with peripheral neuropathic pain for at least 3 month with a pain intensity of at least 4 (0-10) due to polyneuropathy, postherpetic neuralgia or peripheral nerve injury (e.g. postsurgical). At baseline, patients undergo a quantitative sensory testing (QST) (defined in WP 4.3) and patients will be phenotyped with respect to quantitative sensory testing and subdivided into one group with pain suggested to be caused by irritable nociceptors (Nin), defined as preserved cold or warm sensation (detections thresholds within the 95% CI of the reference material and no relative abnormality) and hypersensitivity to touch, pinprick or thermal stimuli), the remainder without this phenotype. Thus, using the nomenclature from the German network, the Nin includes: L0G1, L0G1, L0G2, L0G3, L2G1, L2G2, L2G3 and Nnin all combinations with L1 and L3 and L0G0 and L2G0 (Maier et al. 2010). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria include pregnancy or lactation, allergy to oxcarbazepine, past history of hypersensitivity to carbamazepine or oxcarbazepine, renal or severe hepatic impairment epilepsy, depression and psychiatric disorders. Concomitant medication for neuropathic pain is not allowed but previous treatments for neuropathic pain are not a contraindication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if oxcarbazepine is more efficacious for relief of periperal neuropathic pain in patients with irritable nociceptor pain phenotype than in patients without this phenotype.;Secondary Objective: - to test effect of oxcarbazepine on different pain phenomena in peripheral neuropathic pain - to test if the effect of oxcarbazepine depends on presence of pain paraxysms - to test if the effect of oxcarbazepine depends on pain characteristics as determined by Neuropathic Pain Symptom Inventory - to test if the effect of oxcarbazepine depends sensory profile (quantitaive sensory testing) - to influence of patient expectations on effect of oxcarbazepine and placebo ;Primary end point(s): The primary effect variable will be the change in pain intensity (0-10 NRS) from the baseline week to the last week of treatment (as recorded in diary). A responder is defined as a 50% reduction in pain score (from baseline week to last week of treatment) and response on active drug at least 2 times the reduction observed on placebo. Secondary effect variable will be 1) pain relief (complete, good, moderate, slight, none, or worse), 2) overall period preference, and 3) effect on brush evoked allodynia, cold allodynia, and pinprick hyperalgesia, 4) escape medication (paracetamol) The primary analysis of the study will be the difference in number of responders between Nin and Nnin and the median change in pain score in the total population and each of the two subgroups compared to placebo. | — |
Countries
Denmark
Outcome results
None listed