At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 76 enrolled
Drug / intervention
Ropinirole XL (formerly CR)drug
Likely dose
Ropinirole XL (formerly CR) 2.0mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson's Disease Who Completed the Previous Ropinirole CR Studies 167 or 164
In Brief
A Phase 3 clinical trial evaluating Ropinirole XL (formerly CR) for Parkinson Disease. Completed, enrolled 76 participants across 10 sites.
Detailed Summary
The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2002
First PostedApr 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedApr 1, 2008
Enrollment StartMay 1, 2002
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.3 years ago
Interventions
Ropinirole XL (formerly CR)drug
Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.