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

Parkinson`s Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01338662
• Other study ID #: H-1009-057-332
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2011
• Last updated: May 2, 2017
• Start date: May 2011
• Est. completion date: April 2022

Study information

• Verified date: May 2017
• Source: Seoul National University Hospital
• Contact: Beom S Jeon, MD, PhD
• Phone: 82-2-2072-2876
• Email: brain[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2022
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease
• Parkinson`s Disease

Locations

Country	Name	City	State
Korea, Republic of	Beom S Jeon	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dyskinesia onset	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	UPDRS, severity of dyskinesia between groups	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