Levetiracetam for Painful Polyneuropathy

Odense University Hospital

Status and phase: Completed; Phase 4

Conditions: Painful Polyneuropathy

Treatments: Drug: levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT00286260

keppra2

Details and patient eligibility

About

Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 20 to 0 years
• painful symptoms of polyneuropathy for at least 6 months
• confirmed diagnosis of polyneuropathy
• baseline pain score of 4 or more (0 to 10 point scale)
• pain at least 4 days a week
• adequate anticonceptive treatment for women with childbearing potential
• informed consent

Exclusion criteria

• other cause of pain
• previous allergic reactions towards levetiracetam
• known adverse drug reactions on levetiracetam
• pregnancy
• severe disease
• inability to follow study protocol
• treatment with antidepressants, other anticonvulsants or opioids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind