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

March 9, 2021 updated by: Sandoz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • 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, Korea, Republic of
        • Sandoz Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mMIDI(modified Minnesota Impulsive Disorders Interview)
Time Frame: 12weeks
To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)
12weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric profile
Time Frame: 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)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (ESTIMATE)

September 11, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKL004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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