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Dextromethorphan for the Treatment of Parkinson's Disease and Similar Conditions of the Nervous System
This study has been completed.
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001365
  Purpose

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 Intervention Phase
Neurodegenerative Disease
Parkinson's Disease
Drug: dextromethorphan
Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Degenerative Nerve Diseases Parkinson's Disease
Drug Information available for: Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan Glutamic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Official Title: NMDA Receptor Antagonist Treatment of Neurodegenerative Disease

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

Estimated Enrollment: 42
Study Start Date: July 1993
Estimated Study Completion Date: June 2001
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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001365

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 930183, 93-N-0183
Study First Received: November 3, 1999
Last Updated: July 12, 2006
ClinicalTrials.gov Identifier: NCT00001365  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Dextromethorphan
Dextrorphan
Glutamate Antagonist
Parkinson's Disease

Study placed in the following topic categories:
Excitatory Amino Acids
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Naphazoline
Oxymetazoline
Guaifenesin
Parkinson Disease
Movement Disorders
Phenylephrine
Dextromethorphan
Phenylpropanolamine
Parkinsonian Disorders

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Excitatory Amino Acid Agents
Antitussive Agents
Central Nervous System Agents
Pharmacologic Actions
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 15, 2009