Levetiracetam for Painful Polyneuropathy | NCT00286260

Studies
Levetiracetam for Painful Polyneuropathy

NCT00286260

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Dec 18, 2009Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Painful Polyneuropathy

Interventions

levetiracetam

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Aug 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Feb 1, 2006

First Submission Date that Met QC Criteria

Feb 1, 2006

First Posted Date

Feb 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2009

Last Update Posted Date

Dec 18, 2009Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
levetiracetam	Drug	Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Søren H Sindrup, Professor	Department of Neurology, Odense Unviersity Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Odense University Hospital		Odense C		DK-5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D011115	Polyneuropathies
D009437	Neuralgia

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077287	Levetiracetam

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144

Browse Leaves

Not provided

Browse Branches

Not provided