Levetiracetam for Painful Polyneuropathy

NCT00286260 | Completed Phase 4

• 1 other identifier: keppra2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Painful Polyneuropathy

Keywords

polyneuropathy; neuropathic pain; levetiracetam

Outcome Measures

Primary Outcomes (1)

• Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period)

  Daily

Secondary Outcomes (8)

• Pain rated on 0 to 10 point numeric rating scales

  Daily

• Pain subtypes rated on 0 to 10 point numeric rating scales

  Daily

• Bruch-evoked pain

  Baseline and end of each treament period

• Pin-prick evoked pain

  Baseline and end of each treatment period

• Cold evoked pain

  Baseline and end of each treatment period

Interventions

levetiracetam DRUG

Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Neurology, Odense University Hospital

Odense C, DK-5000, Denmark

Location

MeSH Terms

Conditions

Polyneuropathies; Neuralgia

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Søren H Sindrup, Professor

  Department of Neurology, Odense Unviersity Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 3, 2006
• Study Start: January 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 18, 2009

Record last verified: 2006-01

Locations

DK (1)