Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528

Summary

This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528. Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous. Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.

Timeline

Start

2010-09-02

Primary completion

2012-03-01

Completion

2012-03-28

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper There were no efficacy assessments. PMID 25586298 ↗

Publications

• Zhang Z, Wang J, Zhang X, Chen S, Wang Z, Zhang B, Liu C, Qu Q, Cheng Y, Zhu R, Li J, Hu J, Cai M. An open-label extension study to evaluate the safety of ropinirole prolonged release in Chinese patients with advanced Parkinson's disease. Curr Med Res Opin. 2015 Apr;31(4):723-30. doi: 10.1185/03007995.2015.1005835. Epub 2015 Mar 12.

Drugs

Indications