Efficacy and Safety of Levetiracetam Versus Placebo on Le... | NCT00307450

Studies
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease

NCT00307450

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Aug 3, 2009Estimated

Enrollment

34Estimated

Phase

Phase 4

Conditions

Parkinson's Disease

Interventions

Levetiracetam

Countries

Germany

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

Jul 2009

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

Mar 2006

Primary Completion Date

Mar 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Mar 27, 2006

First Submission Date that Met QC Criteria

Mar 27, 2006

First Posted Date

Mar 28, 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

Jul 31, 2009

Last Update Posted Date

Aug 3, 2009Estimated

Name	Class
UCB Pharma GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.

Detailed Description

The LeLeDys study is designed to determine the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in advanced Parkinson's disease.

The design is a multicenter, randomized, stratified, double-blinded, placebo-controlled phase IV study design.

The hypothesis is that levetiracetam is able to reduce duration and severity of levodopa-induced dyskinesias in Parkinson's disease.

The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.

Main inclusion criteria are:

Advanced Parkinson's disease (Hoehn & Yahr II-IV)
Age of 30 to 80 years
Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
Written informed consent

Main exclusion criteria are:

Atypical parkinsonian syndromes
Treatment with antipsychotics
Epilepsia or seizure in the history
Deep brain stimulation other than DBS in STN
Pregnant or lactating women
Severe dementia

Methods:

Primary outcome measure is the modified AIMS
Secondary outcome measures include UPDRS, safety, patient day record

Study medication:

Levetiracetam (upt to 2000 mg / day)
Matched Placebo

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

34Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levetiracetam	Drug	up to 200 mg per day in two dosages per day.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modified AIMS		11 weeks
UPDRS items 32 & 33		11 weeks

Secondary Outcomes

Measure	Description	Time Frame
UPDRS		11 weeks
Schwab & England scale		11 weeks
Hoehn & Yahr scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced Parkinson's disease (Hoehn & Yahr II-IV)
Age of 30 to 80 years
Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
Written informed consent

Exclusion Criteria:

Atypical parkinsonian syndromes
Treatment with antipsychotics
Epilepsia or seizure in the history
Deep brain stimulation other than DBS in STN
Pregnant or lactating women
Severe dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 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
Alexander Storch, M	Technical University of Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology at the Technical University of Dresden		Dresden		01307	Germany
Department of Neurology at the University of Leipzig

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D020820	Dyskinesias

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System 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

ID	Type	Description	Link
Ethic board no.: EK10012006
EUDRAC no.: 2005-005940-18