NCT00001929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Movement DisordersParkinson Disease

Keywords

DyskinesiasGlutamate AntagonistLevodopa

Interventions

EliprodilDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • 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.

    PMID: 2402638BACKGROUND

  • 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.

    PMID: 2586750BACKGROUND

MeSH Terms

Conditions

Movement DisordersParkinson DiseaseDyskinesias

Interventions

eliprodil

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

March 1, 1999

Study Completion

January 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-01

Locations

US(1)