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

Sponsor
Sandoz (Industry)
Overall Status
Completed
CT.gov ID
NCT01683253
Collaborator
(none)
150
5
3
25
30
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Levodopa/Carbidopa(200mg/50mg)

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

Experimental: Control A (dopaminergic agonist )

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

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

No Intervention: Control B (no drug)

Parkinson diseased patients not treated.

Outcome Measures

Primary Outcome Measures

  1. mMIDI(modified Minnesota Impulsive Disorders Interview) [12weeks]

    To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)

Secondary Outcome Measures

  1. Neuropsychiatric profile [12 weeks]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sandoz Investigative Site Anyang Korea, Republic of
2 Sandoz Investigative Site Daegu Korea, Republic of
3 Sandoz Investigative Site Pusan Korea, Republic of
4 Sandoz Investigative Site Seongnam Korea, Republic of
5 Sandoz Investigative Site Seoul Korea, Republic of

Sponsors and Collaborators

  • Sandoz

Investigators

  • Principal Investigator: Jinwhan Cho, MD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sandoz
ClinicalTrials.gov Identifier:
NCT01683253
Other Study ID Numbers:
  • SKL004
First Posted:
Sep 11, 2012
Last Update Posted:
Mar 10, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021