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OpenTrials
Completed

NCT Number: NCT01683253

Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sandoz Investigative Site, Anyang, South Korea

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levodopa/Carbidopa(200mg/50mg)

Drug

Dopaminergic Agonists

Drug

Treated for at least 6 months after diagnosis of Parkinson's Disease.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study 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

Acronym: REIN-PD

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2012
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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