Levodopa Induced Dyskinesia Clinical Trial
Official title:
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01397422 -
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
|
Phase 2/Phase 3 |