Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease
NCT ID: NCT01673724
Last Updated: 2017-09-15
Study Results
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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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2012-02-29
2016-05-23
Brief Summary
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Detailed Description
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SECONDARY OBJECTIVE
* Evaluate the improvement for Depression which is one of the Nonmotor symptoms
* Evaluate the improvement of clinical symptoms between two groups
* Evaluate the improvement of Quality of Life between two groups
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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pramipexole
dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks
pramipexole
pramipexole
Bromocriptine
bromocriptine dosage form: white round tablet
Bromocriptine
bromocriptine
Interventions
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pramipexole
pramipexole
Bromocriptine
bromocriptine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* modified Hoehn \& Yahr stage \<3
* Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before.
Exclusion Criteria
* History of drug-induced Parkinsonism
* secondary parkinsonism
* History of schizophrenia or hallucination
* Requirement of treatment with anti-depressants due to depressive disorder
* Pregnant and/or breeding women
* Renal inadequacy
30 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Responsible Party
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Principal Investigators
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Seongbeom Koh, MD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Locations
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Korea University Ansan Hospital
Ansan, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Youngnam University Hospital
Daegu, , South Korea
Kangwon Nat'l University Hospital
Kangwon, , South Korea
Inje university Sanggye Paik Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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SKL001
Identifier Type: -
Identifier Source: org_study_id