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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 March 2021 |
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Main ID: |
NCT01683253 |
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Date of registration:
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07/09/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa
REIN-PD |
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Scientific title:
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The REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement Therapy |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01683253 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-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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Jinwhan Cho, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Samsung Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient with a diagnosis of idiopathic PD according to United Kingdom Parkinson's
Disease Brain Bank Criteria
- mMIDI = 3 score with ICD
- Patients must be on an anti-parkinson treatment at least 6 months before screening.
- for this protocol, dopamine agonists should be included in his/her anti-parkinson
treatment.
- 30years = patients < 80years of age, male or female
- patients must give written informed consent before any assessment is performed
Exclusion Criteria:
- Requirement of treatment with serious cognitive disorder, behavioral disorder, or
mental illness currently or in the future
- for the patients = 65years: K-MMSE(korean version of Mini-Mental State Exam) =24, or
for the patients = 66years: K-MMSE = 20, or the patients have dementia(incl. early
dementia) even though K-MMSE score is more than 20
- Requirement of treatment more than 6times per day due to the severe motor fluctuation.
- Severe dyskinesia
- DBS(Deep Brain Stimulation)or any other surgical treatment
- History of melanoma or not-diagnostic skin trouble/skin lesions
- narrow angle glaucoma
- clinically serious surgical or medical condition
- malignant tumor
- use of other investigational drugs at the time of enrollment within 4weeks
- pregnant, nursing or lactating women
- women of child-bearing potential
- history of hypersensitivity or allergy to levodopa/carbidopa
- any serious disease according to the investigator's discretion
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Impulse Control Disorder
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Intervention(s)
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Drug: Dopaminergic Agonists
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Drug: Levodopa/Carbidopa(200mg/50mg)
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Primary Outcome(s)
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mMIDI(modified Minnesota Impulsive Disorders Interview)
[Time Frame: 12weeks]
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Secondary Outcome(s)
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Neuropsychiatric profile
[Time Frame: 12 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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