Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 5:51 AM
Study NCT ID:
NCT00307450
Status:
COMPLETED
Last Update Posted:
2009-08-03
First Post:
2006-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease
Sponsor:
Technische Universität Dresden
Organization:
Study Overview
Official Title:
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LeLeDys
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: