Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease
This trial is active, not recruiting.
|Condition||levodopa induced dyskinesia|
|Sponsor||1st Hospital of Social Security Services|
|Start date||May 2006|
|End date||October 2007|
|Trial size||50 participants|
|Trial identifier||NCT00291733, VALID-PD|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries
time frame: 24 hours
Percent change of "on without dyskinesias" and "off" time from patient diaries. Changes in severity and duration of LID according to the UPDRS , Schwab & England scale and also Goetz dyskinesia scale after a levodopa challenge dose.
time frame: 24 hours
Male or female participants from 30 years up to 80 years old.
- Patients between ages 30 and 80
- Hoehn and Yahr stage of PD over IIb
- Levodopa-induced dyskinesias (LID) despite optimization of antiparkinsonian medication
- LID severity 2 on item 32 and duration 2 on item 33 of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV
- Patient is willing to adhere to protocol requirements as evidence by written informed consent
- Patient has a history of any medical condition or clinically significant laboratory abnormalities that can subject them to unwarranted risk.
- Female patient is pregnant or breastfeeding or has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal.
- Patient with ablative surgeries or DBS implantation electrodes for diseases of the basal ganglia.
- Patient has a low Mini-mental Examination MMSE score <25 or has a history of bipolar psychosis or schizophrenia.
- Patient is unwilling to sign an informed consent or to comply with protocol requirements.
- Patient is taking or has taken in the past month amantadine.
|Official title||Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial|
|Principal investigator||Spiros Konitsiotis, MD|
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