An open-label extension study to evaluate the safety of ropinirole prolonged release in Chinese patients with advanced Parkinson’s disease

Abstract

Objective:

This open-label extension (OLE) study evaluated the safety profile of ropinirole prolonged release (PR) administered for 24 weeks as adjunctive to levodopa in Chinese patients with advanced Parkinson’s disease (PD).

Methods:

This was a 24 week, flexible-dose, OLE study in Chinese patients with advanced PD who received 24 week treatment with ropinirole PR in the preceding double-blind (DB), phase III study (NCT01154166) and had no break in receiving study treatment while switching from the DB study to the OLE study. In the OLE study, patients received ropinirole PR once daily, starting with 2 mg/d and increasing up to 8 mg/d at week 4 (2 mg increment/week); if tolerable, the dose could be further increased in 4 mg increments up to 24 mg/d according to clinical judgment. There were no efficacy assessments. Safety assessments included monitoring adverse events (AEs), neurological examination, Gambling Symptom Assessment Scale questionnaire, liver chemistry, and laboratory tests.

Results:

Of the 295 enrolled patients, 282 completed the study. The most common reason for withdrawal was AEs (n = 9, 3.1%). The mean duration to ropinirole PR treatment was 173.1 days and an overall median daily dose of ropinirole was 8 mg (range: 2–24 mg). Overall, 114 (38.6%) patients experienced on-treatment AEs; the most frequent reported AEs ( ≥ 2%) were dyskinesia (6.1%), dizziness (4.1%), nausea (3.4%), hallucinations (3.4%), somnolence (2.7%) and decreased weight (2.4%). Sixty-eight patients (23.1%) experienced treatment-related AEs. Six patients experienced serious AEs (SAEs), of which hallucination was determined to be a treatment-related SAE. There were no other significant safety findings. No new safety signals for ropinirole were identified.

Conclusion:

The safety profile of ropinirole was consistent with the preceding DB study and also with the established safety profile for ropinirole. Results support the long-term use of ropinirole PR as an adjunctive to levodopa in Chinese patients with advanced PD.

ClinicalTrials.gov identifier:

NCT 1536574.

Key words: :

• Open-label extension
• Parkinson’s disease
• Ropinirole prolonged release
• Safety

Transparency

Declaration of funding

This study was funded by GlaxoSmithKline, which included funding for writing support. The sponsor was involved in the review of the manuscript.

Z.Z., J.W., X.Z., S.C., Z.W., B.Z., C.L., Q.Q., and Y.C. were involved in the study conception and design, data analysis and interpretation. The corresponding author Z.Z. was also involved in revising important intellectual content of the article. All the authors have reviewed the article and approved the final version to be published.

Declaration of financial/other relationships

J.L., J.H., M.C. and R.Z. have disclosed that they are employees of GlaxoSmithKline. Z.Z., J.W., X.Z., S.C., Z.W., B.Z., C.L., Q.Q., and Y.C. have disclosed that they were investigators for this study, and have no other relevant financial relationships to disclose.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank Susan VanMeter, Soraya Shaikh, Teri Jimenez and Maria Davy for critical review of the manuscript and helpful comments. Sanket Jadhav from Tata Consultancy Services Ltd (India) provided writing assistance and Joice Hu from GlaxoSmithKline (China) provided editorial support in preparation of this manuscript. Authors also thank the patients and staff who participated in the study and the following investigators for their contribution to this study: Biao Chen, Haibo Chen, Huifang Shang, Ming Shao, Hongbin Sun, Shenggang Sun, Xiangru Sun, Wenmin Wang, Xin Wang, Weiqin Zhao and Yuhong Zhu.

Notes

*Requipa is a registered trademark of GlaxoSmithKline