Clinical trial NCT01683253: Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impulse Control Disorder
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: mMIDI(modified Minnesota Impulsive Disorders Interview)
timeFrame: 12weeks
Secondary outcomes:
measure: Neuropsychiatric profile
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Sandoz Investigative Site
city: Daegu
country: Korea, Republic of
facility: Sandoz Investigative Site
city: Pusan
country: Korea, Republic of
facility: Sandoz Investigative Site
city: Seongnam
country: Korea, Republic of
facility: Sandoz Investigative Site
city: Seoul
country: Korea, Republic of
facility: Sandoz Investigative Site
Study officials:
affiliation: Samsung Medical Center
name: Jinwhan Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.