Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Levodopa; Ropinirole

Criteria

Inclusion Criteria:

• Idiopathic Parkinson's disease

• Modified Hoehn and Yahr Scale Stages II - IV

• Stable dose of L-dopa for at least 4 weeks prior to screening.

• Lack of control with L-dopa therapy.

• Women of child-bearing potential must use a clinically accepted form of birth control.

Exclusion Criteria:

• Significant and/or uncontrolled medical conditions (excluding Parkinson's disease) within 3 months of screening.

• Any abnormality, at screening, that is considered clinically relevant by the Investigator.

• Dementia

• Use of dopamine agonists within 4 weeks of screening visit.

• Participation in other investigational drug studies.