A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients

Boehringer Ingelheim21 sites in 1 country246 target enrollmentJanuary 2005

ConditionsParkinson Disease

InterventionsMirapex Requip

DrugsMirapex Requip

Overview

Phase: Phase 4
Intervention: Mirapex
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 246
Locations: 21
Primary Endpoint: Expert Panel Overall Assessment Following 2 Years on Drug
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

September 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Mirapex

Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines

Intervention: Mirapex

Requip

Requip tablets three times daily (TID) dosing according to manufacturer's guidelines

Intervention: Requip

Outcomes

Primary Outcomes

Expert Panel Overall Assessment Following 2 Years on Drug

Time Frame: up to 2 years

Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments

Secondary Outcomes

Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years(Baseline, 2 year)
Expert Panel Overall Assessment Following 1 Year on Drug(up to 1 years)
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years(2 years)
Hoehn and Yahr Scale at 2 Years(Up to 2 years)
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year(1 year)
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year(Baseline, 1 year)
Hoehn and Yahr Scale at Baseline(Baseline)
Hoehn and Yahr Scale at 1 Year(Up to 1 year)
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year(1 year)
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years(Baseline, 2 year)
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline(Baseline)
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year(Baseline, 1 year)
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline(Baseline)
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years(2 years)
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years(2 years)
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years(Baseline, 2 year)
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline(Baseline)
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs(Screen (Baseline) and final visit (24 months))
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year(Baseline, 1 year)
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year(1 year)