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

This study is currently recruiting participants.
Verified January 2012 by Seoul National University Hospital
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
History of Changes
  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:

U.S. FDA Resources

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
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
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexol
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on June 18, 2013