Developing Objective Measures of Levodopa Induced Dyskinesia: (Study 1)

NCT00467597 | Completed Results DMC

• 1 other identifier: RCD-003-05F
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The ultimate goal of this proposal is to reduce dyskinesia in Parkinson's Disease (PD) patients. Dyskinesias are abnormal movements, often caused by the standard treatment for PD symptoms, levodopa. In this study, we will test if biochemical devices are equal to the clinical rating system in measuring dyskinesias.

Conditions

Dyskinesias; Movement Disorders; Parkinson Disease

Keywords

Dyskinesia; Levodopa; Movement Disorders; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Gaitmat Stance Measurements (AUC)

  Gaitmat stance measurements were measured every half hour throughout an 8 hour period. Area under the curve was computed using the trapezoidal method for root mean squared velocity in the anterior-posterior direction. Each subject's unique baseline was used by computing the mean of the test-retest period measured at 08:00 am.

  Every 1/2 hour during an 8 hour period.

Study Arms (1)

Group 1

Drug: Levodopa (delivered intravenously)

Interventions

Levodopa (delivered intravenously) DRUG

IV Levodopa is given from 09:00 to 11:00 am during the testing phase of the study. The IV Levodopa allows the researchers to watch one full "on" and "off" levodopa cycle while in the inpatient unit.

Group 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease patients on Levodopa with or without dyskinesia (abnormal involuntary movements caused by levodopa usage).

You may qualify if:

• Clinical diagnosis of probable idiopathic Parkinson's Disease or no neurologic disease (no disease for controls only)
• At least 21 years of age
• Mini Mental Status Exam Score\>=25

You may not qualify if:

• Evidence of psychosis (hallucinations or delusions) by history
• Any unstable medical condition
• Currently using dopamine blocking medication
• Currently taking anticoagulants or MAO inhibitors

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Dyskinesias; Movement Disorders; Parkinson Disease

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Results Point of Contact

• Title: Kathryn Chung, MD
• Organization: Portland VA Health Care System (PORVAHCS)

CHUNGKA@OHSU.EDU

503.220.8262

Study Officials

• Kathryn Anne Chung, MD

  VA Medical Center, Portland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: April 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: October 1, 2013
• Last Updated: November 26, 2014
• Results First Posted: November 26, 2014

Record last verified: 2014-11

Locations

US (1)