NCT01683253

Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Levodopa/Carbidopa(200mg/50mg)
DRUG	Dopaminergic Agonists	Treated for at least 6 months after diagnosis of Parkinson's Disease.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-09-11
• Last updated: 2021-03-10

Locations

5 sites across 1 country: South Korea