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

Condition(s) targeted: Parkinson Disease

Intervention: Requip PD (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Beom S Jeon, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Beom S Jeon, MD, PhD, Phone: 82-2-2072-2876, Email: brain@snu.ac.kr

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

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Patient preference

Secondary outcome:

Motor complications

Sleep problems

Motor UPDRS and HY stage

Side effects

Patient global impression for improvement

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.

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

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

Beom S Jeon, MD, PhD, Phone: 82-2-2072-2876, Email: brain@snu.ac.kr

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Beom S Jeon, MD, PhD, Phone: 82-2-2072-2876, Email: brain@snu.ac.kr
Beom S Jeon, MD, PhD, Principal Investigator
Han J Kim, MD, Sub-Investigator
Ji Y Yun, MD, Sub-Investigator

Related 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.

Starting date: September 2009
Ending date: August 2010
Last updated: October 6, 2009