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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01338662
First received: April 5, 2011
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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
Parkinson`s Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • dyskinesia onset [ Time Frame: up to 10 years from the start of durg (Amantadine or dopaimine agonsit) ] [ Designated as safety issue: No ]
    observe duration of onset of dyskinesia from initial treatment observe until 10 years


Secondary Outcome Measures:
  • UPDRS, severity of dyskinesia between groups [ Time Frame: observe duration of onset of dyskinesia from initial treatment ] [ Designated as safety issue: No ]
    observe duration of onset of dyskinesia from initial treatment observe until 10 years compare the UPDRS and severity of dyskinesia between groups


Estimated Enrollment: 500
Study Start Date: May 2011
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

outpatient clinic in SNUH

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338662

Contacts
Contact: Beom S Jeon, MD, PhD 82-2-2072-2876 brain@snu.ac.kr
Contact: Young Eun Kim, MD 82-2-2072-1219 yeksl99@hanmail.net

Locations
Korea, Republic of
Beom S Jeon Recruiting
Seoul, Korea, Republic of
Contact: Beom S Jeon, MD, PhD    82-2-2072-2876    brain@snu.ac.kr   
Sub-Investigator: Young Eun Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Beom S Jeon, MD, PhD Seoul National University Hospital
  More Information

Publications:
Responsible Party: BS Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01338662     History of Changes
Other Study ID Numbers: H-1009-057-332
Study First Received: April 5, 2011
Last Updated: January 25, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Parkinson`s disease

Additional relevant MeSH terms:
Dyskinesias
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Parkinsonian Disorders
Signs and Symptoms
Amantadine
Dopamine
Dopamine Agents
Dopamine Agonists
Analgesics
Analgesics, Non-Narcotic
Anti-Dyskinesia Agents
Anti-Infective Agents
Antiparkinson Agents
Antiviral Agents
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014