Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-03 @ 9:01 PM
Study NCT ID:
NCT00485069
Status:
COMPLETED
Last Update Posted:
2010-12-15
First Post:
2007-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006.
ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP at \>10mg/day is limited.
For this reason, this study was designed as a multicenter open-label uncontrolled study.
This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn \& Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.
ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP at \>10mg/day is limited.
For this reason, this study was designed as a multicenter open-label uncontrolled study.
This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn \& Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: