Back to resultsTreatment of Parkinson's Disease With Eliprodil
Primary Purpose
Movement Disorders, Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Eliprodil
Sponsored by
About this trial
This is an interventional treatment trial for Movement Disorders focused on measuring Dyskinesias, Glutamate Antagonist, Levodopa
Eligibility Criteria
All patients will carry a diagnosis of idiopathic Parkinson's Disease based on the presence of a characteristic clinical history and neurologic findings. Most will have relatively advanced disease with associated motor response complications. Males and females between the ages of 18-75. No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk. No patients with baseline QTc prolongation (greater than 440 msec). No pregnant women nor those not practicing effective means of birth control.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001929
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00001929
Brief Title
Treatment of Parkinson's Disease With Eliprodil
Official Title
NMDA-Receptor Blockade With Eliprodil in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
Brief Summary
Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This occurs as a result of destructive changes in an area of the brain responsible for making dopamine, the basal ganglia. Patients with the disease experience, rigid muscles, stooped posture, and a shuffling-type walk (gait).
In this study researchers plan to evaluate the effectiveness of the drug eliprodil for the treatment of Parkinson's Disease. Eliprodil works by blocking special receptors (NMDA) that are associated with the symptoms of Parkinson's Disease.
Detailed Description
The objectives of this study are to evaluate the acute effects of the NR2B subtype-selective NMDA antagonist eliprodil on levodopa-associated motor response complications in patients with advanced Parkinson's Disease (PD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorders, Parkinson Disease
Keywords
Dyskinesias, Glutamate Antagonist, Levodopa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Eliprodil
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
All patients will carry a diagnosis of idiopathic Parkinson's Disease based on the presence of a characteristic clinical history and neurologic findings. Most will have relatively advanced disease with associated motor response complications.
Males and females between the ages of 18-75.
No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk.
No patients with baseline QTc prolongation (greater than 440 msec).
No pregnant women nor those not practicing effective means of birth control.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2402638
Citation
Bergman H, Wichmann T, DeLong MR. Reversal of experimental parkinsonism by lesions of the subthalamic nucleus. Science. 1990 Sep 21;249(4975):1436-8. doi: 10.1126/science.2402638.
Results Reference
background
PubMed Identifier
2586750
Citation
Mitchell IJ, Clarke CE, Boyce S, Robertson RG, Peggs D, Sambrook MA, Crossman AR. Neural mechanisms underlying parkinsonian symptoms based upon regional uptake of 2-deoxyglucose in monkeys exposed to 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine. Neuroscience. 1989;32(1):213-26. doi: 10.1016/0306-4522(89)90120-6.
Results Reference
background
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Treatment of Parkinson's Disease With Eliprodil
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