Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa (REIN-PD)
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ClinicalTrials.gov Identifier: NCT01683253 |
Recruitment Status :
Completed
First Posted : September 11, 2012
Last Update Posted : March 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Impulse Control Disorder | Drug: Levodopa/Carbidopa(200mg/50mg) Drug: Dopaminergic Agonists | Phase 4 |
- 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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Levodopa/Carbidopa(200mg/50mg) |
Drug: Levodopa/Carbidopa(200mg/50mg) |
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. |
No Intervention: Control B (no drug)
Parkinson diseased patients not treated.
|
- mMIDI(modified Minnesota Impulsive Disorders Interview) [ Time Frame: 12weeks ]To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)
- Neuropsychiatric profile [ Time Frame: 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)

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683253
Korea, Republic of | |
Sandoz Investigative Site | |
Anyang, Korea, Republic of | |
Sandoz Investigative Site | |
Daegu, Korea, Republic of | |
Sandoz Investigative Site | |
Pusan, Korea, Republic of | |
Sandoz Investigative Site | |
Seongnam, Korea, Republic of | |
Sandoz Investigative Site | |
Seoul, Korea, Republic of |
Principal Investigator: | Jinwhan Cho, MD | Samsung Medical Center |
Responsible Party: | Sandoz |
ClinicalTrials.gov Identifier: | NCT01683253 |
Other Study ID Numbers: |
SKL004 |
First Posted: | September 11, 2012 Key Record Dates |
Last Update Posted: | March 10, 2021 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Disruptive, Impulse Control, and Conduct Disorders Mental Disorders Dopamine Levodopa Carbidopa Dopamine Agonists Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents |
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