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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01515774
First received: January 10, 2012
Last updated: January 18, 2012
Last verified: January 2012
  Purpose
  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 Intervention Phase
Parkinson's Disease
Drug: Mirapex ER
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Patient preference [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Overall preference in QD versus BID


Secondary Outcome Measures:
  • Motor complications [ Time Frame: 2 months at each arm ] [ Designated as safety issue: No ]
    Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration

  • Sleep problems [ Time Frame: 2 months at each arm ] [ Designated as safety issue: No ]
    Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS)

  • Motor UPDRS and HY stage [ Time Frame: 2months at each arm ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 2 months at each arm ] [ Designated as safety issue: Yes ]
    Rating scale (0~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others

  • Patient global impression for improvement [ Time Frame: 2 months at each arm ] [ Designated as safety issue: No ]
  • Preference in each factor [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Preference of QD versus BID in each factor: off duration, off severity, dyskinesia duration, dyskinesia severity, on quality, adverse events, sleep quality, convenience

  • Patient choice [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Patient choice in QD or BID Reason for the choice


Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Give QD dose first then BID dosing
Drug: Mirapex ER
Change Requip or Mirapex to Mirapex ER
Other Name: Mirapex ER
Active Comparator: Group 2
Give BID dosing and then QD dosing
Drug: Mirapex ER
Change Requip or Mirapex to Mirapex ER
Other Name: Mirapex ER

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
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: BS Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01515774     History of Changes
Other Study ID Numbers: H-1104-062-358
Study First Received: January 10, 2012
Last Updated: January 18, 2012
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014