Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa

NCT ID: NCT01683253

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-12-31

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.

Detailed 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

Conditions

Impulse Control Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levodopa/Carbidopa(200mg/50mg)

Group Type: EXPERIMENTAL

Levodopa/Carbidopa(200mg/50mg)

Intervention Type: DRUG

Control A (dopaminergic agonist )

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

Group Type: EXPERIMENTAL

Dopaminergic Agonists

Intervention Type: DRUG

Treated for at least 6 months after diagnosis of Parkinson's Disease.

Control B (no drug)

Parkinson diseased patients not treated.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Levodopa/Carbidopa(200mg/50mg)

Intervention Type: DRUG

Dopaminergic Agonists

Treated for at least 6 months after diagnosis of Parkinson's Disease.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinwhan Cho, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Sandoz Investigative Site

Anyang, , South Korea

Sandoz Investigative Site

Daegu, , South Korea

Sandoz Investigative Site

Pusan, , South Korea

Sandoz Investigative Site

Seongnam, , South Korea

Sandoz Investigative Site

Seoul, , South Korea

Countries

South Korea

References

Lee JY, Jeon B, Koh SB, Yoon WT, Lee HW, Kwon OD, Kim JW, Kim JM, Ma HI, Kim HT, Baik JS, Cho J; (REIN-PD Investigators). Behavioural and trait changes in parkinsonian patients with impulse control disorder after switching from dopamine agonist to levodopa therapy: results of REIN-PD trial. J Neurol Neurosurg Psychiatry. 2019 Jan;90(1):30-37. doi: 10.1136/jnnp-2018-318942. Epub 2018 Oct 25.

Reference Type: DERIVED

PMID: 30361296 (View on PubMed)

Other Identifiers

SKL004

Identifier Type: -

Identifier Source: org_study_id