Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307450
Status:
COMPLETED
Last Update Posted:
2009-08-03
First Post:
2006-03-27
Brief Title:
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinsons Disease
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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 andor 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 Parkinsons 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 Parkinsons 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 andor 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRAC no 2005-005940-18 | None | None | None |
| Ethic board no EK10012006 | None | None | None |