Levetiracetam in Central Pain in Multiple Sclerosis(MS) | NCT00423527

Studies
Levetiracetam in Central Pain in Multiple Sclerosis(MS)

NCT00423527

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Dec 18, 2009Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Multiple Sclerosis

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 2007

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 2007

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jan 16, 2007

First Submission Date that Met QC Criteria

Jan 16, 2007

First Posted Date

Jan 18, 2007Estimated

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

Multiple sclerosis is often associated with pain. There is no standard treatment of this type of pain. Levetiracetam is a new anticonvulsant and it is the hypothesis that it could relieve central pain in multiple sclerosis. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3000 mg daily on pain in multiple sclerosis.

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

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
levetiracetam	Drug	Levetiracetam tablets 500 mg, total daily dose 3000 mg

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 of each period)		Weekly

Secondary Outcomes

Measure	Description	Time Frame
Pain rated on a 0 to 10 point numeric rating scale		Daily
Pain subtypes rated on the same scale.		Daily
Brush-evoked pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ms diagnosis verified
age > 18 years
central pain symptoms for more than 3 months
central pain diagnosis confirmed by neurological examination
adequate anticonceptive treatment for women with child bearing potential
informed consent
baseline pain of more than 4 on numeric rating scale

Exclusion Criteria:

other cause of pain
previous allergic reaction towards levetiracetam
known adverse drug reaction 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

18 Years

Maximum Age

Not provided

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, MD	Department of Neurology, Odense Unviersity Hospital	Principal Investigator

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
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

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