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

Søren H. Sindrup

Status and phase: Completed; Phase 4

Conditions: Polyneuropathy; Postherpetic Neuralgia; Peripheral Nerve Injury

Treatments: Drug: Oxcarbazepine

Study type: Interventional

Funder types: Other

Identifiers

NCT01302275

IMIOXC

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

117 participants in 2 patient groups, including a placebo group

oxcarbazepine

Experimental group

Description:

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.

Treatment:

Drug: Oxcarbazepine

placebo

Placebo Comparator group

Treatment:

Drug: Oxcarbazepine