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

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ClinicalTrials.gov Identifier: NCT01683253
Recruitment Status : Unknown
Verified October 2012 by Sandoz.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Sandoz

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
Impulse Control Disorder Drug: Levodopa/Carbidopa(200mg/50mg) 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Intervention Model: Single Group 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 : November 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683253


Contacts
Contact: kim +82 2 768 9422

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

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01683253     History of Changes
Other Study ID Numbers: SKL004
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Levodopa
Carbidopa
Dopamine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors