Status:
COMPLETED
Talampanel to Treat Parkinson's Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study will evaluate the effects of the experimental drug talampanel on dyskinesias (involuntary movements) that develop in patients with Parkinson's disease as a result of long-term treatment wit...
Detailed Description
Objective: to evaluate the acute effects of talampanel, a novel antagonist of AMPA type glutamate receptors, on the severity of parkinsonian signs and levodopa-associated motor response complications....
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients who meet all of the following inclusion criteria on Study Day 1 will be eligible to participate in the study:
- Between the ages of 21 and 80, inclusive;
- Has been diagnosed with idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurologic findings;
- Has relatively advanced disease with levodopa-associated motor response complications, including ratable peak-dose dyskinesias and wearing-off fluctuations;
- Patient is willing to adhere to protocol requirements as evidenced by written, informed consent;
- Patient is satisfactorily treated with levodopa with or without short acting dopamine agonist.
- EXCLUSION CRITERIA:
- Patients meeting any of the following exclusion criteria either at Day 0 or during the study will not be enrolled or will be immediately withdrawn from the study, as appropriate:
- Has a history of any medical condition that can reasonably be expected to subject them to unwarranted risk, including lung disease, liver disease and clinically significant cardiac arrhythmias and/or myocardial ischemia;
- Has clinically significant laboratory abnormalities including liver enzyme elevation; positivity to any of the autoantibodies tested at Screening (ANA, RF, anti-SM, anti-LKM)
- Is unable to be treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist, such as pramipexole or ropinirole;
- Unable or unwilling to discontinue a prohibited concomitant medication as listed below; allowable CNS medications will be maintained at a constant dose throughout the study;
- Has not been using an adequate contraceptive method for the last 30 days or unwilling to continue, or is not at least one year post-menopausal (if female);
- Is pregnant or breastfeeding;
- Is implanted with bilateral deep brain stimulators unless the stimulators are turned off during the entire study;
- Has prior bilateral pallidotomy or other ablative surgeries for treatment of PD;
- Has cognitive impairment (MMSE less than 25);
- Has participated in a clinical study with an investigational drug within the last 30 days;
- Has a condition (such as active drug or alcohol abuse) that, in the opinion of the investigators, would interfere with compliance or safety;
- Is unwilling to sign an informed consent or to comply with protocol requirements.
- Unilateral and bilateral pallidotomy
- History of alcoholism.
- Orthostatic Hypotension
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00108667
Start Date
April 1 2005
End Date
February 1 2006
Last Update
March 4 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892