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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Parkinson Disease

Treatments: Drug: ropinirole immediate release; Drug: Ropinirole prolonged release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00331149

ROP105323

Details and patient eligibility

About

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

Enrollment: 343 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.