Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 7:08 PM
Study NCT ID:
NCT00291733
Status:
UNKNOWN
Last Update Posted:
2007-11-15
First Post:
2006-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease
Sponsor:
1st Hospital of Social Security Services
Organization:
Study Overview
Official Title:
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge characteristics of basal ganglia. From the other hand, LEV which shares a different electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of abnormal neuronal firing in experimental models of epilepsy. LEV also reduces levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates "priming phenomenon" which associated with long-term changes in synaptic function that can lead to dyskinesias in PD.
Study objectives :
* To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo on disabling dyskinesias that develop as result of long-term treatment with levodopa, occurring at the time of maximal clinical improvement in patients with Parkinson's disease (PD).
* To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.
Study objectives :
* To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo on disabling dyskinesias that develop as result of long-term treatment with levodopa, occurring at the time of maximal clinical improvement in patients with Parkinson's disease (PD).
* To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: