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

Sponsor:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00986245

Purpose

In order to observe the benefit, side effects, and patient preference of Requip PD when used in QD or BID dosing
In order to estimate the conversion rate of dopamine agonists into Requip PD

Condition	Intervention	Phase
Parkinson Disease	Drug: Requip PD	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Ropinirole hydrochloride Ropinirole

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:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator Give QD dose first then BID dosing	Drug: Requip PD Change Requip or Mirapex to Requip PD
Group 2: Active Comparator Give BID dosing and then QD dosing	Drug: Requip PD Change Requip or Mirapex to Requip PD

Detailed Description:

Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Requip PD
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
Dose adjustment may be done in the first 4 weeks.
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:

Age: 30-80
Parkinson disease
On dopamine agonists (requip or Mirapex) and are considering to change into requip PD
On stable antiparkinsonian medication for at least 4 weeks
Who signed consent to the study

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986245

Contacts

Contact: Beom S Jeon, MD, PhD	82-2-2072-2876	brain@snu.ac.kr
Contact: Han J Kim, MD	82-2-2072-0388	movement@snuh.org

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
Principal Investigator: Beom S Jeon, MD, PhD
Sub-Investigator: Han J Kim, MD
Sub-Investigator: Ji Y Yun, MD

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

Beom S Jeon, MD, PhD

Seoul National University Hospital

More Information

Publications:

Lyons KE, Pahwa R. An open-label conversion study of pramipexole to ropinirole prolonged release in Parkinson's disease. Mov Disord. 2009 Sep 18; [Epub ahead of print]

Stocchi F, Hersh BP, Scott BL, Nausieda PA, Giorgi L; Ease-PD Monotherapy Study Investigators. Ropinirole 24-hour prolonged release and ropinirole immediate release in early Parkinson's disease: a randomized, double-blind, non-inferiority crossover study. Curr Med Res Opin. 2008 Oct;24(10):2883-95. Epub 2008 Sep 2.

Responsible Party:	Seoul National University Hospital ( Beom S. Jeon, Professor )
Study ID Numbers:	0908-037-290
Study First Received:	September 24, 2009
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00986245 History of Changes
Health Authority:	Korea: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Antiparkinson Agents
Dopamine Agonists

Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010