Parkinson's DiseasePhase 4NCT01515774
Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)
A Phase 4 study testing Mirapex ER in people with Parkinson's Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
1. In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing 2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Mirapex ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Oct 2012
- 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
- Age: 30-80
- Parkinson disease
- On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER
- On stable antiparkinsonian medication for at least 4 weeks
- Who signed consent to the study
Who cannot join
- Who are on less than 2 mg of Requip or 0.375 mg of Mirapex
- Who have dementia, psychosis, major depression and other serious neurological or medical problems
- Who are allergic to the similar medications
- Who has history of heavy metal poisoning
- Who were on othe clinical trials of other medications within the last 4 weeks
- Who are pregnant or lactating
- Who are considered not eligible by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Beom S. Jeon, MD, PhD, 82-2-2072-2876, brain@snu.ac.kr
Ji Y Yun, MD, 82-2-2072-0359, dream-yoon@hanmail.net
About this study
Official title: An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease
- In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing
- In order to estimate the conversion rate of dopamine agonists into Mirapex ER
Read the detailed description
- Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER
- Cross over study design:
- Group 1: Once daily dose for 2 month then into BID in divided dose for 2 months
- Group 2: BID in divided dose for 2 months then into QD dose for 2 months
- Dose adjustment may be done in the first 4 weeks.
- Compare the benefit, side effects, and patient preference between the QD vs BID dosing
- Conditions
- Parkinson's Disease
- Being tested
- Mirapex ER
- Keywords
- Parkinson's disease, Pramipexole
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirapex ERDrug
Change Requip or Mirapex to Mirapex ER
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Give QD dose first then BID dosing Receives: Drug: Mirapex ER |
| Group 2 | Active comparator | Give BID dosing and then QD dosing Receives: Drug: Mirapex ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preference
Overall preference in QD versus BID
Measured: 4 months
Secondary outcomes (7)
Motor complications
Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration
Measured: 2 months at each arm
Sleep problems
Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS)
Measured: 2 months at each arm
Motor UPDRS and HY stage
Measured: 2months at each arm
Side effects
Rating scale (0~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others
Measured: 2 months at each arm
Patient global impression for improvement
Measured: 2 months at each arm
Preference in each factor
Preference of QD versus BID in each factor: off duration, off severity, dyskinesia duration, dyskinesia severity, on quality, adverse events, sleep quality, convenience
Measured: 4 months
Patient choice
Patient choice in QD or BID Reason for the choice
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionAug 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BS Jeon, Seoul National University Hospital
- Investigators
- Beom S Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515774
- Sponsor's protocol ID
- H-1104-062-358
- Status last verified
- Jan 2012
- First submitted
- 10 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jenner P, Konen-Bergmann M, Schepers C, Haertter S. Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies. Clin Ther. 2009 Nov;31(11):2698-711. doi: 10.1016/j.clinthera.2009.10.018.
PubMed 20110012Rascol O, Barone P, Hauser RA, Mizuno Y, Poewe W, Schapira AH, Salin L, Sohr M, Debieuvre C; Pramipexole Switch Study Group. Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease. Mov Disord. 2010 Oct 30;25(14):2326-32. doi: 10.1002/mds.23262.
PubMed 20669265Yun JY, Kim YE, Yang HJ, Kim HJ, Jeon B. Twice-Daily versus Once-Daily Pramipexole Extended Release Dosage Regimens in Parkinson's Disease. Parkinsons Dis. 2017;2017:8518929. doi: 10.1155/2017/8518929. Epub 2017 Feb 7.
PubMed 28265478
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT01515774
- Acronym / sponsor ID
- H-1104-062-358
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Pramipexole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 24 Jan 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.
- In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing
- In order to estimate the conversion rate of dopamine agonists into Mirapex ER
Detailed description
- Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER
- Cross over study design:
- Group 1: Once daily dose for 2 month then into BID in divided dose for 2 months
- Group 2: BID in divided dose for 2 months then into QD dose for 2 months
- Dose adjustment may be done in the first 4 weeks.
- Compare the benefit, side effects, and patient preference between the QD vs BID dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Mirapex ERGive QD dose first then BID dosing |
| Group 2 | Active comparator | Drug: Mirapex ERGive BID dosing and then QD dosing |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 30-80
- Parkinson disease
- On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER
- On stable antiparkinsonian medication for at least 4 weeks
- Who signed consent to the study
Key exclusion criteria (7 listed)
- Who are on less than 2 mg of Requip or 0.375 mg of Mirapex
- Who have dementia, psychosis, major depression and other serious neurological or medical problems
- Who are allergic to the similar medications
- Who has history of heavy metal poisoning
- Who were on othe clinical trials of other medications within the last 4 weeks
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 |
|---|---|---|
| Mirapex ERChange Requip or Mirapex to Mirapex ER | Drug | Group 1, Group 2 |
Primary outcome
Patient preference
Time frame: 4 months
Overall preference in QD versus BID
7 secondary outcomes
Motor complications
Time frame: 2 months at each arm
Sleep problems
Time frame: 2 months at each arm
Motor UPDRS and HY stage
Time frame: 2months at each arm
Side effects
Time frame: 2 months at each arm
Patient global impression for improvement
Time frame: 2 months at each arm
Preference in each factor
Time frame: 4 months
Patient choice
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
- Background: PubMed 20110012Jenner P, Konen-Bergmann M, Schepers C, Haertter S. Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies. Clin Ther. 2009 Nov;31(11):2698-711. doi: 10.1016/j.clinthera.2009.10.018.
- Background: PubMed 20669265Rascol O, Barone P, Hauser RA, Mizuno Y, Poewe W, Schapira AH, Salin L, Sohr M, Debieuvre C; Pramipexole Switch Study Group. Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease. Mov Disord. 2010 Oct 30;25(14):2326-32. doi: 10.1002/mds.23262.
- Derived from this study: PubMed 28265478Yun JY, Kim YE, Yang HJ, Kim HJ, Jeon B. Twice-Daily versus Once-Daily Pramipexole Extended Release Dosage Regimens in Parkinson's Disease. Parkinsons Dis. 2017;2017:8518929. doi: 10.1155/2017/8518929. Epub 2017 Feb 7.
Related trials for Parkinson's Disease
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
Not yet recruiting
The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease
Parkinson Disease
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
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.
Beom S Jeon, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirapex ER in people with Parkinson's Disease, run by Seoul National University Hospital at 1 site 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beom S Jeon, MD, PhD (82-2-2072-2876, brain@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient preference (time frame: 4 months). 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 NCT01515774, which also lists 3 linked publications.
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 24 Jan 2012; AzTrials last refreshed its copy on 8 Nov 2026.