Status:
UNKNOWN
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease
Lead Sponsor:
1st Hospital of Social Security Services
Collaborating Sponsors:
UCB Pharma
Conditions:
Levodopa Induced Dyskinesia
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank.
- Other inclusion criteria:
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00291733
Start Date
May 1 2006
End Date
October 1 2007
Last Update
November 15 2007
Active Locations (1)
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1
Department of Neurology, 1st Hospital of Social Security Services
Athens, Greece, 151-27