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

This study is not yet open for participant recruitment.
Verified October 2012 by Sandoz Korea
Sponsor:
Information provided by (Responsible Party):
Sandoz Korea
ClinicalTrials.gov Identifier:
NCT01683253
First received: September 7, 2012
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Impulse Control Disorder
 Drug: Levodopa/Carbidopa(200mg/50mg)
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sandoz Korea:

Primary Outcome Measures:
  • mMIDI(modified Minnesota Impulsive Disorders Interview) [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
    To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)


Secondary Outcome Measures:
  • Neuropsychiatric profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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)


Estimated Enrollment: 78
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levodopa/Carbidopa(200mg/50mg) Drug: Levodopa/Carbidopa(200mg/50mg)

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 accordidng to the investigator's discretion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683253

Contacts
Contact: kim +82 2 768 9422

Sponsors and Collaborators
Sandoz Korea
Investigators
Principal Investigator: Jinwhan Cho, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Sandoz Korea
ClinicalTrials.gov Identifier: NCT01683253     History of Changes
Other Study ID Numbers: SKL004
Study First Received: September 7, 2012
Last Updated: October 10, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Impulse Control Disorders
Mental Disorders
Carbidopa
Levodopa
Dopamine
Dopamine Agonists
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents

ClinicalTrials.gov processed this record on June 17, 2013