AMPA Receptor Blockade With LY300164 in the Treatment of Parkinson's Disease
LY300164
Synucleinopathies+10
+ Basal Ganglia Diseases
+ Brain Diseases
Treatment Study
Summary
Study start date: February 1, 2000
Actual date on which the first participant was enrolled.The objective of this study is to evaluate the acute effects of alpha-amino-3-hydroxy-5-methyl-4-isoxazole proprionic acid (AMPA) receptor blockade on the severity of parkinsonian signs and levodopa-associated motor response complications in patients with Parkinson's disease. In a controlled proof-of-principle clinical trial, efficacy will be assessed through the use of validated motor function scales. Safety will be monitored by means of frequent clinical evaluations and laboratory tests.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Males and females between the ages of 30 and 75 are eligible for the study. All will carry the diagnosis of idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurological findings. All will have relatively advanced disease (Hoehn and Yahr Stages II to IV) with levodopa-associated motor response complications, including wearing-off fluctuations and peak-dose dyskinesias. No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk. No clinically significant laboratory abnormalities including liver enzyme elevations more than three times the upper limit of normal, or neutropenia (WBC less than 4000). No parkinson's disease patients exhibiting diphasic or end-of-dose dyskinesias or disabling dystonia. Since LY300164 is an inhibitor of CP4503A4, patients receiving certain drugs metabolized by that pathway will not be included. No patients who are unable to be treated with levodopa/carbidopa alone or a single, relatively short-acting dopamine agonist. No patients who require additional treatment with amantadine or other concomitant medications. No pregnant women or those not practicing effective means of birth control since the influence of any investigational compound on the unborn child and reproductive organs is unknown.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, United StatesOpen National Institute of Neurological Disorders and Stroke (NINDS) in Google Maps