title: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Neurology, Peking Union Medical College Hospital , Beijing , China.
authors.forename: Zhenxin
authors.initials: Z
authors.lastname: Zhang
authors.forename: Jian
authors.initials: J
authors.lastname: Wang
authors.forename: Xiaoying
authors.initials: X
authors.lastname: Zhang
authors.forename: Shengdi
authors.initials: S
authors.lastname: Chen
authors.forename: Zhenfu
authors.initials: Z
authors.lastname: Wang
authors.forename: Baorong
authors.initials: B
authors.lastname: Zhang
authors.forename: Chunfeng
authors.initials: C
authors.lastname: Liu
authors.forename: Qiumin
authors.initials: Q
authors.lastname: Qu
authors.forename: Yan
authors.initials: Y
authors.lastname: Cheng
authors.forename: Rongxuan
authors.initials: R
authors.lastname: Zhu
authors.forename: Jie
authors.initials: J
authors.lastname: Li
authors.forename: Jingqiu
authors.initials: J
authors.lastname: Hu
authors.forename: Meng
authors.initials: M
authors.lastname: Cai
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D003692:Delayed-Action Preparations; D065546:Drug Liberation; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000978:Antiparkinson Agents; D003692:Delayed-Action Preparations; D007211:Indoles; C046649:ropinirole; D007980:Levodopa
keywords: Open-label extension; Parkinson’s disease; Ropinirole prolonged release; Safety