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

Primary Purpose

Impulse Control Disorder

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Levodopa/Carbidopa(200mg/50mg)
Dopaminergic Agonists
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impulse Control Disorder

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sandoz Investigative Site
  • Sandoz Investigative Site
  • Sandoz Investigative Site
  • Sandoz Investigative Site
  • Sandoz Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Levodopa/Carbidopa(200mg/50mg)

Control A (dopaminergic agonist )

Control B (no drug)

Arm Description

Parkinson patients treated with anti-Parkinson drug over 6 months.

Parkinson diseased patients not treated.

Outcomes

Primary Outcome Measures

mMIDI(modified Minnesota Impulsive Disorders Interview)
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
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)

Full Information

First Posted
September 7, 2012
Last Updated
March 9, 2021
Sponsor
Sandoz
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1. Study Identification

Unique Protocol Identification Number
NCT01683253
Brief Title
Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa
Acronym
REIN-PD
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 Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulse Control Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levodopa/Carbidopa(200mg/50mg)
Arm Type
Experimental
Arm Title
Control A (dopaminergic agonist )
Arm Type
Experimental
Arm Description
Parkinson patients treated with anti-Parkinson drug over 6 months.
Arm Title
Control B (no drug)
Arm Type
No Intervention
Arm Description
Parkinson diseased patients not treated.
Intervention Type
Drug
Intervention Name(s)
Levodopa/Carbidopa(200mg/50mg)
Intervention Type
Drug
Intervention Name(s)
Dopaminergic Agonists
Intervention Description
Treated for at least 6 months after diagnosis of Parkinson's Disease.
Primary Outcome Measure Information:
Title
mMIDI(modified Minnesota Impulsive Disorders Interview)
Description
To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)
Time Frame
12weeks
Secondary Outcome Measure Information:
Title
Neuropsychiatric profile
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinwhan Cho, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandoz Investigative Site
City
Anyang
Country
Korea, Republic of
Facility Name
Sandoz Investigative Site
City
Daegu
Country
Korea, Republic of
Facility Name
Sandoz Investigative Site
City
Pusan
Country
Korea, Republic of
Facility Name
Sandoz Investigative Site
City
Seongnam
Country
Korea, Republic of
Facility Name
Sandoz Investigative Site
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30361296
Citation
Lee JY, Jeon B, Koh SB, Yoon WT, Lee HW, Kwon OD, Kim JW, Kim JM, Ma HI, Kim HT, Baik JS, Cho J; (REIN-PD Investigators). Behavioural and trait changes in parkinsonian patients with impulse control disorder after switching from dopamine agonist to levodopa therapy: results of REIN-PD trial. J Neurol Neurosurg Psychiatry. 2019 Jan;90(1):30-37. doi: 10.1136/jnnp-2018-318942. Epub 2018 Oct 25.
Results Reference
derived

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Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa

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