Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa

Study Overview
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Brief Summary
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The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist to levodopa/carbidopa in patients with Parkinson's disease who have been treated with dopaminergic medications.

Detailed Description
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PRIMARY OBJECTIVE To evaluate the improvement of mMIDI(modified version of Minnesota Impulsive Disorders Interview,Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward) SECONDARY OBJECTIVE i) To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF ii) To evaluate the improvement of UPDRS(Unified Parkinson's Disease Rating Scale)Score from the baseline to 12 weeks or LOCF

Official 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

Conditions
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Impulse Control Disorder

Intervention / Treatment
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* Drug: Levodopa/Carbidopa(200mg/50mg)
* Drug: Dopaminergic Agonists


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levodopa/Carbidopa(200mg/50mg)<br> | Drug: Levodopa/Carbidopa(200mg/50mg)<br> <br> |
| Experimental: Control A (dopaminergic agonist )<br>Parkinson patients treated with anti-Parkinson drug over 6 months. | Drug: Dopaminergic Agonists<br>* Treated for at least 6 months after diagnosis of Parkinson's Disease.<br>|
| No Intervention: Control B (no drug)<br>Parkinson diseased patients not treated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mMIDI(modified Minnesota Impulsive Disorders Interview) | To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward) | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric profile | To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF * Neuropsychological assessment General cognitive status: K-Minimental status exam(K-MMSE) Psychiatric profile: Neuropsychiatric inventory (K-NPI) Beck depression inventory (BDI) Barratt impulsiveness scale (BIS) Beck anxiety inventory (BAI) State-trait anger expression inventory (STAXI) Obsessive compulsive inventory (OCI) Evaluation of global change: Patient global impression of improvement (PGI-I) Clinical global impression of improvement (CGI-I) | 12 weeks |