Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa

Impulse Control Disorder Clinical Trial

— REIN-PD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683253
• Other study ID #: SKL004
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2021
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Impulse Control Disorder

Intervention

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

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mMIDI(modified Minnesota Impulsive Disorders Interview)	To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)	12weeks
Secondary	Neuropsychiatric profile	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)	12 weeks