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

Parkinson's Disease Clinical Trial

Official title:

NMDA Receptor Antagonist Treatment of Neurodegenerative Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001365
• Other study ID #: 930183
• Secondary ID: 93-N-0183
• Status: Completed
• Phase: Phase 2
• First received: November 3, 1999
• Last updated: July 12, 2006
• Start date: July 1993
• Est. completion date: June 2001

Study information

• Verified date: July 2000
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurodegenerative Disease
• Neurodegenerative Diseases
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• dextromethorphan

Locations

Country	Name	City	State
United States	National Institute of Neurological Disorders and Stroke (NINDS)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

Verhagen Metman L, Blanchet PJ, van den Munckhof P, Del Dotto P, Natté R, Chase TN. A trial of dextromethorphan in parkinsonian patients with motor response complications. Mov Disord. 1998 May;13(3):414-7. — View Citation