NCT00001365

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 1993

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1993

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

July 13, 2006

Status Verified

July 1, 2000

First QC Date

November 3, 1999

Last Update Submit

July 12, 2006

Conditions

Keywords

DextromethorphanDextrorphanGlutamate AntagonistParkinson's Disease

Interventions

Eligibility Criteria

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

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)

  • 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.

    PMID: 9195602BACKGROUND
  • 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.

    PMID: 9613730BACKGROUND

MeSH Terms

Conditions

Neurodegenerative DiseasesParkinson Disease

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Nervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathies

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

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

July 1, 1993

Study Completion

June 1, 2001

Last Updated

July 13, 2006

Record last verified: 2000-07

Locations