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Status unknownNCT01515774Updated Jan 24, 2012

Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)

A Phase 4 interventional study of Mirapex ER in Parkinson's Disease, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-01-24.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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 the detailed description
  1. Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER

  2. 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
  3. Dose adjustment may be done in the first 4 weeks.
  4. Compare the benefit, side effects, and patient preference between the QD vs BID dosing
02

Conditions studied

  • Parkinson's Disease

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Keywords

  • Parkinson's disease
  • Pramipexole
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 200 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age: 30-80
  2. Parkinson disease
  3. On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER
  4. On stable antiparkinsonian medication for at least 4 weeks
  5. Who signed consent to the study

Exclusion criteria

Exclusion Criteria:

  1. Who are on less than 2 mg of Requip or 0.375 mg of Mirapex
  2. Who have dementia, psychosis, major depression and other serious neurological or medical problems
  3. Who are allergic to the similar medications
  4. Who has history of heavy metal poisoning
  5. Who were on othe clinical trials of other medications within the last 4 weeks
  6. Who are pregnant or lactating
  7. Who are considered not eligible by the investigator
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Group 1

    Give QD dose first then BID dosing

    Drug: Mirapex ER

  • Active comparator
    Group 2

    Give BID dosing and then QD dosing

    Drug: Mirapex ER

Interventions

  • DrugMirapex ER

    Change Requip or Mirapex to Mirapex ER

06

What researchers measure

Primary outcomes

  1. Patient preference

    Overall preference in QD versus BID

    Time frame: 4 months

Secondary outcomes

  1. Motor complications

    Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration

    Time frame: 2 months at each arm

  2. Sleep problems

    Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS)

    Time frame: 2 months at each arm

  3. Motor UPDRS and HY stage

    Time frame: 2months at each arm

  4. Side effects

    Rating scale (0\~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others

    Time frame: 2 months at each arm

  5. Patient global impression for improvement

    Time frame: 2 months at each arm

  6. 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

    Time frame: 4 months

  7. Patient choice

    Patient choice in QD or BID Reason for the choice

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
    • Beom S. Jeon, MD, PhD · Contact · brain@snu.ac.kr · 82-2-2072-2876
    • Ji Y Yun, MD · Contact · dream-yoon@hanmail.net · 82-2-2072-0359
    • Beom S. Jeon, MD, PhD · Principal investigator
    • Han-Joon Kim, MD · Sub investigator
    • Ji Y Yun, MD · Sub investigator
    • Young Eun Kim, MD · Sub investigator
    Recruiting
08

References and documents

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 20110012 ↗
  • Rascol 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 20669265 ↗
  • Yun 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01515774
Lead sponsor
Seoul National University Hospital
Responsible party
BS Jeon (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 24, 2012
Start date
Sep 2011
Primary completion
Aug 2012 (estimated)
Completion
Oct 2012 (estimated)
Last update
Jan 24, 2012

Study contacts

Beom S Jeon, MD, PhD
Contact
brain@snu.ac.kr
82-2-2072-2876
Ji Young Yun, MD
Contact
dream-yoon@hanmail.net
82-2-2072-0359
Beom S Jeon, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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