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

NCT ID: NCT01338662

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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BS Jeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beom S Jeon, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Beom S Jeon

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Beom S Jeon, MD, PhD

Role: CONTACT

82-2-2072-2876

Young Eun Kim, MD

Role: CONTACT

82-2-2072-1219

Facility Contacts

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Beom S Jeon, MD, PhD

Role: primary

82-2-2072-2876

References

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Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.

Reference Type BACKGROUND
PMID: 10816186 (View on PubMed)

Montastruc JL, Rascol O, Senard JM, Rascol A. A randomised controlled study comparing bromocriptine to which levodopa was later added, with levodopa alone in previously untreated patients with Parkinson's disease: a five year follow up. J Neurol Neurosurg Psychiatry. 1994 Sep;57(9):1034-8. doi: 10.1136/jnnp.57.9.1034.

Reference Type BACKGROUND
PMID: 8089666 (View on PubMed)

Other Identifiers

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H-1009-057-332

Identifier Type: -

Identifier Source: org_study_id

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