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Dextromethorphan for the Treatment of Parkinson's Disease and Similar Conditions of the Nervous System

Primary Purpose

Neurodegenerative Disease, Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dextromethorphan
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurodegenerative Disease focused on measuring Dextromethorphan, Dextrorphan, Glutamate Antagonist, Parkinson's Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Parkinson's disease or other neurodegenerative disorders in which excessive stimulation of central glutamatergic pathways is hypothesized. Patients must be in good general health and have no history or clinical evidence of significant cardiac (including dysrhythmias), pulmonary, gastrointestinal, renal, hepatic, endocrine, hematological or psychiatric disease. Patient must not evidence any disorder which in the opinion of the investigator imposes an unnecessary risk to the patient or compromises the scientific interpretation of the data. Individuals of child bearing potential must practice appropriate methods of birth control.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
July 12, 2006
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001365
Brief Title
Dextromethorphan for the Treatment of Parkinson's Disease and Similar Conditions of the Nervous System
Official Title
NMDA Receptor Antagonist Treatment of Neurodegenerative Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2000
Overall Recruitment Status
Completed
Study Start Date
July 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
This study is designed to determine whether dextromethorphan, a drug commonly found in cough medicine, is beneficial and safe for the treatment of Parkinson's disease and other diseases that might share biochemical abnormalities with Parkinson's disease. 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. Rhythmical muscular tremors, rigidity of movement, shuffling footsteps, droopy posture, and a mask-like expression on the face characterize Parkinson's disease. Researchers believe that dextromethorphan may be able to safely modify psychomotor function of patients with Parkinson's Disease.
Detailed Description
The ability of the putative excitatory amino acid receptor antagonist, dextromethorphan, to modify psychomotor function safely in patients with neurodegenerative disease will be evaluated using a modified double-blind placebo-controlled design. Therapeutic activity will be rated at various doses by means of standard motor and cognitive performance scales. Safety will be assessed at frequent intervals by clinical observation and laboratory tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodegenerative Disease, Parkinson's Disease
Keywords
Dextromethorphan, Dextrorphan, Glutamate Antagonist, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dextromethorphan

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Parkinson's disease or other neurodegenerative disorders in which excessive stimulation of central glutamatergic pathways is hypothesized. Patients must be in good general health and have no history or clinical evidence of significant cardiac (including dysrhythmias), pulmonary, gastrointestinal, renal, hepatic, endocrine, hematological or psychiatric disease. Patient must not evidence any disorder which in the opinion of the investigator imposes an unnecessary risk to the patient or compromises the scientific interpretation of the data. Individuals of child bearing potential must practice appropriate methods 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
9195602
Citation
Blanchet PJ, Papa SM, Metman LV, Mouradian MM, Chase TN. Modulation of levodopa-induced motor response complications by NMDA antagonists in Parkinson's disease. Neurosci Biobehav Rev. 1997 Jul;21(4):447-53. doi: 10.1016/s0149-7634(96)00038-3.
Results Reference
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PubMed Identifier
9613730
Citation
Verhagen Metman L, Blanchet PJ, van den Munckhof P, Del Dotto P, Natte R, Chase TN. A trial of dextromethorphan in parkinsonian patients with motor response complications. Mov Disord. 1998 May;13(3):414-7. doi: 10.1002/mds.870130307.
Results Reference
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Dextromethorphan for the Treatment of Parkinson's Disease and Similar Conditions of the Nervous System

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