- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01683253
Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa (REIN-PD)
March 9, 2021 updated by: Sandoz
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
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
- Sandoz Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Levodopa/Carbidopa(200mg/50mg)
|
|
EXPERIMENTAL: Control A (dopaminergic agonist )
Parkinson patients treated with anti-Parkinson drug over 6 months.
|
Treated for at least 6 months after diagnosis of Parkinson's Disease.
|
NO_INTERVENTION: Control B (no drug)
Parkinson diseased patients not treated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
12weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychiatric profile
Time Frame: 12 weeks
|
To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF * Neuropsychological assessment
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jinwhan Cho, MD, Samsung Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
September 7, 2012
First Submitted That Met QC Criteria
September 7, 2012
First Posted (ESTIMATE)
September 11, 2012
Study Record Updates
Last Update Posted (ACTUAL)
March 10, 2021
Last Update Submitted That Met QC Criteria
March 9, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Disruptive, Impulse Control, and Conduct Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Protective Agents
- Cardiotonic Agents
- Dopamine Agents
- Sympathomimetics
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Dopamine
- Carbidopa
- Dopamine Agonists
Other Study ID Numbers
- SKL004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Impulse Control Disorder
-
Laval UniversityUnknownImpulse Control DisorderCanada
-
Centre Hospitalier Universitaire, AmiensUnknownParkinson | Impulse Control DisorderFrance
-
Boehringer IngelheimCompleted
-
Duke UniversityNational Institute of Mental Health (NIMH)RecruitingMood Disorders | Obsessive-Compulsive Disorder | Anxiety Disorders | OCD | Borderline Personality Disorder | Stress Disorder | Emotional Distress | Emotion Regulation | Eating Disorders | Emotion Dysregulation | Emotional Dysfunction | Emotional Impulsivity | Emotional Instability | Impulse Control Disorder | Emotional...United States
-
Massachusetts General HospitalForest LaboratoriesCompletedImpulse Control DisordersUnited States
-
Massachusetts General HospitalPfizerCompletedImpulse Control DisordersUnited States
-
Promentis Pharmaceuticals, Inc.Baylor College of Medicine; CelerionCompletedImpulse Control DisordersUnited States
-
West Virginia UniversityNot yet recruitingParkinson Disease | Impulse Control DisorderUnited States
-
Boehringer IngelheimCompleted
-
Indonesia UniversityRadboud University Medical CenterNot yet recruiting
Clinical Trials on Levodopa/Carbidopa(200mg/50mg)
-
Huashan HospitalBoehringer IngelheimCompletedIdiopathic Parkinson's DiseaseChina
-
Ascletis Pharmaceuticals Co., Ltd.CompletedChronic Hepatitis cChina
-
University of MinnesotaNot yet recruitingIdiopathic Parkinson DiseaseUnited States
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.CompletedDiabetic Neuropathy PeripheralChina
-
Global Alliance for TB Drug DevelopmentCompleted
-
Orion Corporation, Orion PharmaTerminatedParkinson´s DiseaseFinland
-
AbbVie (prior sponsor, Abbott)Completed
-
Centre for Addiction and Mental HealthCompleted
-
NeuroDerm Ltd.Quotient ClinicalCompletedParkinson's DiseaseUnited Kingdom
-
Snyder, Robert W., M.D., Ph.D., P.C.WithdrawnAge-related Macular DegenerationUnited States