NCT01683253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2012

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

September 7, 2012

Last Update Submit

March 9, 2021

Conditions

Impulse Control Disorder

Outcome Measures

Primary Outcomes (1)

  • 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)

    12weeks

Secondary Outcomes (1)

  • Neuropsychiatric profile

    12 weeks

Study Arms (3)

Levodopa/Carbidopa(200mg/50mg)

EXPERIMENTAL
Drug: Levodopa/Carbidopa(200mg/50mg)

Control A (dopaminergic agonist )

EXPERIMENTAL

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

Drug: Dopaminergic Agonists

Control B (no drug)

NO INTERVENTION

Parkinson diseased patients not treated.

Interventions

Levodopa/Carbidopa(200mg/50mg)DRUG
Levodopa/Carbidopa(200mg/50mg)
Dopaminergic AgonistsDRUG

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

Control A (dopaminergic agonist )

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • years ≤ patients \< 80years of age, male or female
  • patients must give written informed consent before any assessment is performed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sandoz Investigative Site

Anyang, South Korea

Location

Sandoz Investigative Site

Daegu, South Korea

Location

Sandoz Investigative Site

Pusan, South Korea

Location

Sandoz Investigative Site

Seongnam, South Korea

Location

Sandoz Investigative Site

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30361296DERIVED

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders

Interventions

LevodopaCarbidopaDopamine Agonists

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosineMethyldopaHydrazinesDopamine AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Jinwhan Cho, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 11, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

KR(5)