Talampanel to Treat Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00108667
• Date of registration: 15/04/2005
• Prospective Registration: No
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Talampanel to Treat Parkinson's Disease
• Scientific title: AMPA Receptor Antagonist Treatment of Parkinson's Disease
• Date of first enrolment: April 2005
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00108667
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

Patients who meet all of the following inclusion criteria on Study Day 1 will be eligible
to participate in the study:

1. Between the ages of 21 and 80, inclusive;

2. Has been diagnosed with idiopathic Parkinson's disease based on the presence of a
characteristic clinical history and neurologic findings;

3. Has relatively advanced disease with levodopa-associated motor response
complications, including ratable peak-dose dyskinesias and wearing-off fluctuations;

4. Patient is willing to adhere to protocol requirements as evidenced by written,
informed consent;

5. 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study will not be enrolled or will be immediately withdrawn from the study, as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:

1. 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;

2. Has clinically significant laboratory abnormalities including liver enzyme elevation;
positivity to any of the autoantibodies tested at Screening (ANA, RF, anti-SM,
anti-LKM)

3. Is unable to be treated with levodopa/carbidopa alone or with a single, relatively
short-acting dopamine agonist, such as pramipexole or ropinirole;

4. 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;

5. 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);

6. Is pregnant or breastfeeding;

7. Is implanted with bilateral deep brain stimulators unless the stimulators are turned
off during the entire study;

8. Has prior bilateral pallidotomy or other ablative surgeries for treatment of PD;

9. Has cognitive impairment (MMSE less than 25);

10. Has participated in a clinical study with an investigational drug within the last 30
days;

11. Has a condition (such as active drug or alcohol abuse) that, in the opinion of the
investigators, would interfere with compliance or safety;

12. Is unwilling to sign an informed consent or to comply with protocol requirements.

13. Unilateral and bilateral pallidotomy

14. History of alcoholism.

15. Orthostatic Hypotension



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: IV Levodopa

Drug: Talampanel

Secondary ID(s)

05-N-0139

050139

Source(s) of Monetary Support

Please refer to primary and secondary sponsors