REIN-PD: Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
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)
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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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Levodopa/Carbidopa(200mg/50mg)
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Drug: Levodopa/Carbidopa(200mg/50mg)
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Experimental: Control A (dopaminergic agonist ) Parkinson patients treated with anti-Parkinson drug over 6 months. |
Drug: Dopaminergic Agonists
Treated for at least 6 months after diagnosis of Parkinson's Disease.
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No Intervention: Control B (no drug) Parkinson diseased patients not treated. |
Outcome Measures
Primary Outcome Measures
- mMIDI(modified Minnesota Impulsive Disorders Interview) [12weeks]
To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)
Secondary Outcome Measures
- Neuropsychiatric profile [12 weeks]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient with a diagnosis of idiopathic PD according to United Kingdom Parkinson's Disease Brain Bank Criteria
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mMIDI ≥ 3 score with ICD
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Patients must be on an anti-parkinson treatment at least 6 months before screening.
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for this protocol, dopamine agonists should be included in his/her anti-parkinson treatment.
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30years ≤ patients < 80years of age, male or female
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patients must give written informed consent before any assessment is performed
Exclusion Criteria:
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Requirement of treatment with serious cognitive disorder, behavioral disorder, or mental illness currently or in the future
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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
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Requirement of treatment more than 6times per day due to the severe motor fluctuation.
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Severe dyskinesia
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DBS(Deep Brain Stimulation)or any other surgical treatment
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History of melanoma or not-diagnostic skin trouble/skin lesions
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narrow angle glaucoma
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clinically serious surgical or medical condition
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malignant tumor
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use of other investigational drugs at the time of enrollment within 4weeks
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pregnant, nursing or lactating women
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women of child-bearing potential
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history of hypersensitivity or allergy to levodopa/carbidopa
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any serious disease according to the investigator's discretion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Sandoz Investigative Site | Anyang | Korea, Republic of | ||
2 | Sandoz Investigative Site | Daegu | Korea, Republic of | ||
3 | Sandoz Investigative Site | Pusan | Korea, Republic of | ||
4 | Sandoz Investigative Site | Seongnam | Korea, Republic of | ||
5 | Sandoz Investigative Site | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Sandoz
Investigators
- Principal Investigator: Jinwhan Cho, MD, Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SKL004