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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01683253
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Sandoz

Study Description
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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) Drug: Dopaminergic Agonists 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
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Study Type : Interventional  (Clinical Trial)
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 : November 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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)


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
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 according to the investigator's discretion
Contacts and Locations
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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


Locations
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Korea, Republic of
Sandoz Investigative Site
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
Sponsors and Collaborators
Sandoz
Investigators
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Principal Investigator: Jinwhan Cho, MD Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01683253    
Other Study ID Numbers: SKL004
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Dopamine
Levodopa
Carbidopa
Dopamine Agonists
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents