CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 246 enrolled
Drug / intervention
Mirapex +1 moredrug
Likely dose
Pramipexole IR (Mirapex) and ropinirole (Requip) at standard marketed doses per manufacturer guidelinesAI-extracted
Key inclusion· 5
  • ✓Idiopathic Parkinson's disease, Stage I-III by Modified Hoehn and Yahr Scale, diagnosed less than 7 years ago
  • ✓Maximum 6 months cumulative lifetime exposure to levodopa and/or dopamine agonist
  • ✓Age at least 30 years
  • ✓Women of childbearing potential must have negative serum beta-HCG pregnancy test and use adequate contraception
Key exclusion· 20
  • ✕Prior allergic response or complications with any dopaminergic agonist drug
  • ✕Atypical Parkinson's disease syndromes
  • ✕Folstein's Mini Mental State Examination (MMSE) score of 24 or less
  • ✕Active epilepsy/seizure in past 1 year

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00144300
NCT00144300Phase 4Completed
CompareCT.gov

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 Ingelheim·interventional·Posted Sep 5, 2005·Updated Mar 14, 2014

In Brief

A Phase 4 clinical trial evaluating Mirapex and Requip for Parkinson Disease. Completed, enrolled 246 participants across 21 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartJan 1, 2005
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.8 years ago

Interventions

Mirapexdrug

Standard marketed product dispensed according to manufacturer's guidelines

Requipdrug

Standard marketed product dispensed according to manufacturer's guidelines