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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Sandoz.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Sandoz Identifier:
First received: September 7, 2012
Last updated: October 10, 2012
Last verified: October 2012
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:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • 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:
  • 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)

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

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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 accordidng to the investigator's discretion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01683253

Contact: kim +82 2 768 9422

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

Responsible Party: Sandoz Identifier: NCT01683253     History of Changes
Other Study ID Numbers: SKL004
Study First Received: September 7, 2012
Last Updated: October 10, 2012

Additional relevant MeSH terms:
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors processed this record on June 23, 2017