Treatment of Parkinson's Disease With Eliprodil

This study has been completed.

First Received: November 3, 1999 Last Updated: March 3, 2008 History of Changes

Sponsor:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001929

Purpose

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.

Condition	Intervention	Phase
Movement Disorders Parkinson Disease	Drug: Eliprodil	Phase II

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study
Official Title:	NMDA-Receptor Blockade With Eliprodil in Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Movement Disorders Parkinson's Disease

Drug Information available for: Eliprodil

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	20
Study Start Date:	March 1999
Estimated Study Completion Date:	January 2001

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).

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001929

Locations

United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

More Information

Publications:

Bergman H, Wichmann T, DeLong MR. Reversal of experimental parkinsonism by lesions of the subthalamic nucleus. Science. 1990 Sep 21;249(4975):1436-8.

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.

Study ID Numbers:	990078, 99-N-0078
Study First Received:	November 3, 1999
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00001929 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Dyskinesias
Glutamate Antagonist
Levodopa

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Excitatory Amino Acid Agents
Brain Diseases
Neurodegenerative Diseases
Protective Agents

Neuroprotective Agents
Pharmacologic Actions
Eliprodil
Movement Disorders
Parkinson Disease
Therapeutic Uses
Parkinsonian Disorders
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on November 30, 2009