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

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ClinicalTrials.gov Identifier: NCT01338662
Recruitment Status : Recruiting
First Posted : April 19, 2011
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):

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
Parkinson`s Disease

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
Estimated 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 2011
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

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

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