Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease
Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study
1 other identifier
interventional
121
1 country
7
Brief Summary
The purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in Parkinson's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2012
Longer than P75 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 23, 2012
CompletedFirst Posted
Study publicly available on registry
August 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2016
CompletedSeptember 15, 2017
September 1, 2017
4.3 years
August 23, 2012
September 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
K-NMSS
Evaluate The total and each category score of K-NMSS
24 weeks
Secondary Outcomes (3)
K-MADRS
24 weeks
UPDRS I/II/III
24 weeks
K-PDQ39
24 weeks
Study Arms (2)
pramipexole
EXPERIMENTALdosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks
Bromocriptine
ACTIVE COMPARATORbromocriptine dosage form: white round tablet
Interventions
Eligibility Criteria
You may qualify if:
- Parkinson's disease patients in accordance with UK Queensquare Brain Bank
- 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.
You may not qualify if:
- K-MMSE\<24
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
Study Sites (7)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seongbeom Koh, MD
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2012
First Posted
August 28, 2012
Study Start
February 1, 2012
Primary Completion
May 23, 2016
Study Completion
May 23, 2016
Last Updated
September 15, 2017
Record last verified: 2017-09