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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01338662
Collaborator
(none)
500
Enrollment
1
Location
131
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    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
    Study Start Date :
    May 1, 2011
    Anticipated Primary Completion Date :
    Apr 1, 2020
    Anticipated Study Completion Date :
    Apr 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. dyskinesia onset [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

    Secondary Outcome Measures

    1. UPDRS, severity of dyskinesia between groups [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beom S Jeon Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    BS Jeon, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01338662
    Other Study ID Numbers:
    • H-1009-057-332
    First Posted:
    Apr 19, 2011
    Last Update Posted:
    May 3, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by BS Jeon, Professor, Seoul National University Hospital
    Parkinson's disease
    Additional relevant MeSH terms:
    Parkinson Disease
    Dyskinesias

    Study Results

    No Results Posted as of May 3, 2017