Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT01673724 |
Date of registration:
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23/08/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease
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Scientific title:
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Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study |
Date of first enrolment:
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February 2012 |
Target sample size:
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121 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01673724 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Seongbeom Koh, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Korea University Guro Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Bromocriptine
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Drug: pramipexole
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Primary Outcome(s)
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K-NMSS
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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K-MADRS
[Time Frame: 24 weeks]
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UPDRS I/II/III
[Time Frame: 24 weeks]
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K-PDQ39
[Time Frame: 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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