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

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ClinicalTrials.gov Identifier: NCT01515774
Recruitment Status : Unknown
Verified January 2012 by BS Jeon, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : January 24, 2012
Last Update Posted : January 24, 2012
Sponsor:
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Mirapex ER Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group 1
Give QD dose first then BID dosing
Drug: Mirapex ER
Change Requip or Mirapex to Mirapex ER
Active Comparator: Group 2
Give BID dosing and then QD dosing
Drug: Mirapex ER
Change Requip or Mirapex to Mirapex ER



Primary Outcome Measures :
  1. Patient preference [ Time Frame: 4 months ]
    Overall preference in QD versus BID


Secondary Outcome Measures :
  1. Motor complications [ Time Frame: 2 months at each arm ]
    Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration

  2. Sleep problems [ Time Frame: 2 months at each arm ]
    Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS)

  3. Motor UPDRS and HY stage [ Time Frame: 2months at each arm ]
  4. Side effects [ Time Frame: 2 months at each arm ]
    Rating scale (0~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others

  5. Patient global impression for improvement [ Time Frame: 2 months at each arm ]
  6. Preference in each factor [ Time Frame: 4 months ]
    Preference of QD versus BID in each factor: off duration, off severity, dyskinesia duration, dyskinesia severity, on quality, adverse events, sleep quality, convenience

  7. Patient choice [ Time Frame: 4 months ]
    Patient choice in QD or BID Reason for the choice



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515774


Contacts
Contact: Beom S Jeon, MD, PhD 82-2-2072-2876 brain@snu.ac.kr
Contact: Ji Young Yun, MD 82-2-2072-0359 dream-yoon@hanmail.net

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Beom S. Jeon, MD, PhD    82-2-2072-2876    brain@snu.ac.kr   
Contact: Ji Y Yun, MD    82-2-2072-0359    dream-yoon@hanmail.net   
Principal Investigator: Beom S. Jeon, MD, PhD         
Sub-Investigator: Han-Joon Kim, MD         
Sub-Investigator: Ji Y Yun, MD         
Sub-Investigator: Young Eun Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Beom S Jeon, MD, PhD Seoul National University Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BS Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01515774     History of Changes
Other Study ID Numbers: H-1104-062-358
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012

Keywords provided by BS Jeon, Seoul National University Hospital:
Parkinson's disease
Pramipexole

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents