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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Seoul National University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00986245
First received: September 24, 2009
Last updated: February 22, 2011
Last verified: February 2011
History of Changes
  Purpose
  1. In order to observe the benefit, side effects, and patient preference of Requip PD when used in QD or BID dosing
  2. In order to estimate the conversion rate of dopamine agonists into Requip PD

Condition Intervention Phase
Parkinson Disease
 Drug: Requip PD
 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 Requip PD® and Twice-daily Requip PD® 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 ]

Secondary Outcome Measures:
  • Motor complications [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Sleep problems [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Motor UPDRS and HY stage [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Patient global impression for improvement [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Give QD dose first then BID dosing
 Drug: Requip PD
Change Requip or Mirapex to Requip PD
Other Name: Requip PD
Active Comparator: Group 2
Give BID dosing and then QD dosing
 Drug: Requip PD
Change Requip or Mirapex to Requip PD
Other Name: Requip PD

Detailed Description:
  1. Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Requip PD

  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 requip PD
  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. Whoa re 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: NCT00986245

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Boramae City Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Beom S Jeon, MD, PhD Seoul National University Hospital
  More Information

Publications:

Responsible Party: Beom S. Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00986245     History of Changes
Other Study ID Numbers: 0908-037-290
Study First Received: September 24, 2009
Last Updated: February 22, 2011
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 13, 2013