Impulse Control DisorderPhase 4REIN-PDNCT01683253
Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa
A Phase 4 study testing Levodopa/Carbidopa(200mg/50mg) and Dopaminergic Agonists in people with Impulse Control Disorder, run by Sandoz at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Impulse Control Disorder
- What is being tested?
- Levodopa/Carbidopa(200mg/50mg) and Dopaminergic Agonists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Nov 2012to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Sandoz Investigative Site
Anyang
Sandoz Investigative Site
Daegu
Sandoz Investigative Site
Pusan
Sandoz Investigative Site
Seongnam
Sandoz Investigative Site
Seoul
About this study
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
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.
Read the 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
- Conditions
- Impulse Control Disorder
- Being tested
- Levodopa/Carbidopa(200mg/50mg), Dopaminergic Agonists
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa/Carbidopa(200mg/50mg)Drug
Dopaminergic AgonistsDrug
Treated for at least 6 months after diagnosis of Parkinson's Disease.
| Study group | Role | What they receive |
|---|---|---|
| Levodopa/Carbidopa(200mg/50mg) | Experimental | Not described Receives: Drug: Levodopa/Carbidopa(200mg/50mg) |
| Control A (dopaminergic agonist ) | Experimental | Parkinson patients treated with anti-Parkinson drug over 6 months. Receives: Drug: Dopaminergic Agonists |
| Control B (no drug) | No intervention | Parkinson diseased patients not treated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12weeks
Secondary outcomes (1)
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impulse Control DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinwhan Cho, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683253
- Sponsor's protocol ID
- SKL004
- Acronym
- REIN-PD
- Status last verified
- Mar 2021
- First submitted
- 7 Sep 2012
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
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.
PubMed 30361296
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01683253
- Acronym / sponsor ID
- REIN-PD / SKL004
- Conditions
- Impulse Control Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levodopa/Carbidopa(200mg/50mg) | Experimental | Drug: Levodopa/Carbidopa(200mg/50mg) |
| Control A (dopaminergic agonist ) | Experimental | Drug: Dopaminergic AgonistsParkinson patients treated with anti-Parkinson drug over 6 months. |
| Control B (no drug) | No intervention | –Parkinson diseased patients not treated. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa/Carbidopa(200mg/50mg) | Drug | Levodopa/Carbidopa(200mg/50mg) |
| Dopaminergic AgonistsTreated for at least 6 months after diagnosis of Parkinson's Disease. | Drug | Control A (dopaminergic agonist ) |
Primary outcome
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)
1 secondary outcome
Neuropsychiatric profile
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 30361296Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinwhan Cho, MD principal investigator
Samsung Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levodopa/Carbidopa(200mg/50mg) and Dopaminergic Agonists in people with Impulse Control Disorder, run by Sandoz at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mMIDI(modified Minnesota Impulsive Disorders Interview) (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.