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

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ClinicalTrials.gov Identifier: NCT00001365
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : July 13, 2006
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Neurodegenerative Disease Parkinson's Disease Drug: dextromethorphan Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
Primary Purpose: Treatment
Official Title: NMDA Receptor Antagonist Treatment of Neurodegenerative Disease
Study Start Date : July 1993
Study Completion Date : June 2001

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001365


Locations
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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
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Publications:

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ClinicalTrials.gov Identifier: NCT00001365    
Other Study ID Numbers: 930183
93-N-0183
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: July 13, 2006
Last Verified: July 2000
Keywords provided by National Institutes of Health Clinical Center (CC):
Dextromethorphan
Dextrorphan
Glutamate Antagonist
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Excitatory Amino Acid Antagonists
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs