Status:
COMPLETED
Levetiracetam Treatment of L-dopa Induced Dyskinesias
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Dyskinesias
Parkinson Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study will evaluate the effects of levetiracetam (Keppra (Trademark) on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment wit...
Detailed Description
Introduction: Parkinson's disease is a progressive degenerative disease of unknown etiology. Its treatment has been symptomatic and the most successful approach has been to replace the missing dopamin...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients who meet all of the following inclusion criteria will be able to participate in the study:
- Patient is between the ages of 30 and 80, inclusive;
- Patient has been diagnosed with idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurological findings;
- Patient has relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations ;
- Patient is willing to adhere to protocol requirements as evidenced by written, informed consent.
- EXCLUSION CRITERIA:
- Patients meeting any of the following exclusion criteria will not be enrolled or immediately withdrawn from the study, as appropriate:
- Patient has a history of any medical condition that can reasonably be expected to subject them to unwaranted risk;
- Patient has clinically significant laboratory abnormalities including impaired renal function (CL(cr) equals 30-50 ml/min.);
- Patient is uable to br treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist, such as pramipexole or ropinirole;
- Patient is taking a prohibited concomitant medication;
- Patient 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 (if female);
- Patient is pregnant or breastfeeding;
- Patient is implanted with bilateral deep brain stimulators;
- Patient has prior pallidotomy or other ablative surgeries for treatment of PD;
- Patient has cognitive impairment (MMSE less than 25);
- Patient has participated in a clinical study with an investigational drug within the last 30 days;
- Patient has a condition (such as active drug or alcohol abuse) that, in the opinion of the investigators, would interfere with compliance or safety;
- Patient is unwilling to sign an informed consent or to comply with protocol requirements;
- Patient has a history of psychiatric illness.
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00076674
Start Date
January 1 2004
End Date
October 1 2005
Last Update
September 22 2016
Active Locations (1)
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1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892