Comparison of the Incidence of Dyskinesia in Parkinson's Disease Who Were Treated With Amantadine or Dopamine Agonist

May 2, 2017 updated by: BS Jeon, Seoul National University Hospital

A 10-year Observational Study of the Incidence of Dyskinesia in Patients With Early Parkinson's Disease Who Were Treated With Amantadine or Dopamine Agonist

The purpose of this study is to compare the onset time and severity of dyskinesia in amantadine or Dopamine agonist initial treated groups in Parkinson's disease.

Study Overview

Status

Unknown

Conditions

Detailed Description

  1. Dopamine agonist can delay the risk of dyskinesia by initiating treatment rather than levodopa. Amantadine is typical antidyskinetic drug. There is no data about comparison of risk of dyskinesia in amantadine and dopamine agonist by initiating treatment.
  2. Prospective , randomized, open label study compare the onset time and severity of dyskinesia between groups randomized assigned order of amantadine and dopamine agonist

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

outpatient clinic in SNUH

Description

Inclusion Criteria:

  • 30<age<60
  • IPD
  • H & Y<3

Exclusion Criteria:

  • previous dopaminergic medication history
  • dyskinesia
  • Parkinson plus
  • clinically significant or unstable medical or surgical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group A-1
  • study enroll number 3n+1 (N=0,1,2...)
  • initial treatment- amantadine
  • add levodopa when the patient become to need further treatment.
Group A-2
  • study enroll number 3n+2 (N=0,1,2...)
  • initial treatment: amantadine
  • add dopamine agonist when the patient become to need further treatment.
Group B
  • study enroll number 3n+3 (N=0,1,2...)
  • initial treatment: dopamine agonist
  • add levodopa when the patient become to need further treatment. but cannot use amantadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dyskinesia onset
Time Frame: up to 10 years from the start of durg (Amantadine or dopaimine agonsit)
observe duration of onset of dyskinesia from initial treatment observe until 10 years
up to 10 years from the start of durg (Amantadine or dopaimine agonsit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UPDRS, severity of dyskinesia between groups
Time Frame: observe duration of onset of dyskinesia from initial treatment
observe duration of onset of dyskinesia from initial treatment observe until 10 years compare the UPDRS and severity of dyskinesia between groups
observe duration of onset of dyskinesia from initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Beom S Jeon, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1009-057-332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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