Back to resultsPramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pramipexole
Bromocriptine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Korea University Ansan Hospital
- Inje University Busan Paik Hospital
- Youngnam University Hospital
- Kangwon Nat'l University Hospital
- Inje university Sanggye Paik Hospital
- Korea University Anam Hospital
- Korea University Guro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pramipexole
Bromocriptine
Arm Description
dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks
bromocriptine dosage form: white round tablet
Outcomes
Primary Outcome Measures
K-NMSS
Evaluate The total and each category score of K-NMSS
Secondary Outcome Measures
K-MADRS
Evaluate the Improvement of the depression refering to the total score of K-MADRS
UPDRS I/II/III
Evaluate the improvement of UPDRS I/II/III
K-PDQ39
Evaluate the improvement of Patient's QOL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01673724
Brief Title
Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease
Official Title
Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 23, 2016 (Actual)
Study Completion Date
May 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pramipexole
Arm Type
Experimental
Arm Description
dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks
Arm Title
Bromocriptine
Arm Type
Active Comparator
Arm Description
bromocriptine dosage form: white round tablet
Intervention Type
Drug
Intervention Name(s)
pramipexole
Other Intervention Name(s)
Sandoz Pramipexole
Intervention Description
pramipexole
Intervention Type
Drug
Intervention Name(s)
Bromocriptine
Other Intervention Name(s)
Parlodel tab
Intervention Description
bromocriptine
Primary Outcome Measure Information:
Title
K-NMSS
Description
Evaluate The total and each category score of K-NMSS
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
K-MADRS
Description
Evaluate the Improvement of the depression refering to the total score of K-MADRS
Time Frame
24 weeks
Title
UPDRS I/II/III
Description
Evaluate the improvement of UPDRS I/II/III
Time Frame
24 weeks
Title
K-PDQ39
Description
Evaluate the improvement of Patient's QOL
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seongbeom Koh, MD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Youngnam University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Kangwon Nat'l University Hospital
City
Kangwon
Country
Korea, Republic of
Facility Name
Inje university Sanggye Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease
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