A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

Condition(s) targeted: Parkinson's Disease

Intervention: Ropinirole prolonged release (Drug); ropinirole immediate release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed in many countries. The new prolonged release formulation allows the drug to be taken once a day rather than three times a day. This study will also evaluate the side effects of the new prolonged release formulation of ropinirole

Official title: A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-Dopa.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Diary information to compare the amount of time "off"(time "off" includes a lack of mobility with or without additional features such as tremor or rigidity)the patient experiences at the start and end of the study.

Secondary outcome: Compare the score on Parkinson's disease and quality of life scales at the start and end of the study. Assess change in L-dopa dose. Incidence of adverse events.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Patients with a diagnosis of advanced idiopathic Parkinson's disease (according to

modified Hoehn & Yahr criteria Stages II-IV) whose symptoms are not adequately controlled with L-dopa.

Exclusion criteria:

- Patients with late stage advanced Parkinson's disease with incapacitating dyskinesias

on a stable dose of L-dopa.

- Current, or history of, (within the previous 3 months), significant and/or

uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy.

- Recent history of severe dizziness or fainting on standing.

- Dementia, neurotic behaviour, crippling degenerative arthritis or limb amputations, or

prior or current major psychosis.

- Recent history or current evidence of drug abuse or alcoholism.

- Use of a dopamine agonist within 4 weeks of starting the study.

- Personal or family history of an allergic reaction to ropinirole.

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Starting date: May 2006
Ending date: August 2007
Last updated: June 9, 2008