Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa (REIN-PD)

Sandoz

Status and phase: Completed; Phase 4

Conditions: Impulse Control Disorder

Treatments: Drug: Dopaminergic Agonists; Drug: Levodopa/Carbidopa(200mg/50mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01683253

SKL004

Details and patient eligibility

About

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.

Full description

• 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

Enrollment: 150 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Levodopa/Carbidopa(200mg/50mg)

Experimental group

Treatment:

Drug: Levodopa/Carbidopa(200mg/50mg)

Control A (dopaminergic agonist )

Experimental group

Description:

Parkinson patients treated with anti-Parkinson drug over 6 months.

Treatment:

Drug: Dopaminergic Agonists

Control B (no drug)

No Intervention group

Description:

Parkinson diseased patients not treated.