Parkinson's DiseaseNCT01338662
Comparison of the Incidence of Dyskinesia in Parkinson's Disease Who Were Treated With Amantadine or Dopamine Agonist
An observational study of Parkinson's Disease, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: outpatient clinic in SNUH
Who may be able to join
- 30<age<60
- IPD
- H \& Y<3
Who cannot join
- previous dopaminergic medication history
- dyskinesia
- Parkinson plus
- clinically significant or unstable medical or surgical condition
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Beom S Jeon
Seoul
Beom S Jeon, MD, PhD, 82-2-2072-2876, brain@snu.ac.kr
Young Eun Kim, MD
About this study
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
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.
Read the detailed description
- 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.
- Prospective , randomized, open label study compare the onset time and severity of dyskinesia between groups randomized assigned order of amantadine and dopamine agonist
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
dyskinesia onset
observe duration of onset of dyskinesia from initial treatment observe until 10 years
Measured: up to 10 years from the start of durg (Amantadine or dopaimine agonsit)
Secondary outcomes (1)
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
Measured: observe duration of onset of dyskinesia from initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2020 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BS Jeon, Seoul National University Hospital
- Investigators
- Beom S Jeon, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338662
- Sponsor's protocol ID
- H-1009-057-332
- Status last verified
- May 2017
- First submitted
- 5 Apr 2011
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10816186Montastruc 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.
PubMed 8089666
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01338662
- Acronym / sponsor ID
- H-1009-057-332
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- outpatient clinic in SNUH
Key inclusion criteria (3 listed)
- 30<age<60
- IPD
- H \& Y<3
Key exclusion criteria (4 listed)
- previous dopaminergic medication history
- dyskinesia
- Parkinson plus
- clinically significant or unstable medical or surgical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
UPDRS, severity of dyskinesia between groups
Time frame: observe duration of onset of dyskinesia from initial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Background: PubMed 10816186Rascol 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.
- Background: PubMed 8089666Montastruc 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beom S Jeon, MD, PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beom S Jeon, MD, PhD (82-2-2072-2876, brain@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dyskinesia onset (time frame: up to 10 years from the start of durg (Amantadine or dopaimine agonsit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01338662, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.