Levetiracetam for Painful Polyneuropathy

This study is currently recruiting participants.

Verified by Odense University Hospital, January 2006

First Received: February 1, 2006 No Changes Posted

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00286260

Purpose

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

Condition	Intervention	Phase
Painful Polyneuropathy	Drug: levetiracetam	Phase IV

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Double-Blind, Randomised, Placebo-Controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Pain rated on 0 to 10 point numeric rating scales
Pain subtypes rated on 0 to 10 point numeric rating scales
Bruch-evoked pain
Pin-prick evoked pain
Cold evoked pain
Health related quality of life(SF-36)
Pain related sleep disturbance
Use of escape medication

Estimated Enrollment:	40
Study Start Date:	January 2006
Estimated Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286260

Contacts

Contact: Søren H Sindrup, professor	+45 65412471	soeren.sindrup@ouh.fyns-amt.dk
Contact: Marit Otto, registrar	+45 65412472

Locations

Denmark
Department of Neurology, Odense University Hospital	Recruiting
Odense C, Denmark, DK-5000
Contact: Søren H Sindrup, Professor +45 65412471 soeren.sindrup@ouh.fyns-amt.dk
Principal Investigator: Søren H Sindrup, professor
Sub-Investigator: Marit Otto, Registrar

Sponsors and Collaborators

Odense University Hospital

Investigators

Study Chair:

Søren H Sindrup, Professor

Department of Neurology, Odense Unviersity Hospital

More Information

No publications provided

Study ID Numbers:	keppra2
Study First Received:	February 1, 2006
Last Updated:	February 1, 2006
ClinicalTrials.gov Identifier:	NCT00286260 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:

polyneuropathy
neuropathic pain
levetiracetam

Study placed in the following topic categories:

Nootropic Agents
Signs and Symptoms
Neuromuscular Diseases
Peripheral Nervous System Diseases
Polyneuropathies
Piracetam

Neurologic Manifestations
Etiracetam
Pain
Neuroprotective Agents
Anticonvulsants

Additional relevant MeSH terms:

Nootropic Agents
Physiological Effects of Drugs
Nervous System Diseases
Polyneuropathies
Pain
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Signs and Symptoms

Neuromuscular Diseases
Peripheral Nervous System Diseases
Therapeutic Uses
Neurologic Manifestations
Piracetam
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009