Clinical Trial: Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients With Restless Legs Syndrome (RLS)

Brief Summary: The primary objective of this study is to assess the safety and tolerability of ropinirole XR in the long-term treatment (up to 52 weeks)of adults with RLS.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Incidence/severity of adverse events Changes in vital signs Labs ECG Assessment of augmentation and rebound (worsening of RLS symptoms). [ Time Frame: Up to 52 Weeks ]

Original Primary Outcome:

  • Incidence/severity of adverse events
  • Changes in vital signs
  • Labs
  • ECG
  • Assessment of augmentation and rebound (worsening of RLS symptoms).


Current Secondary Outcome:

  • Change from baseline in IRLS Rating Scale total score CGI Scale scores Medical Outcomes Study Sleep Scale scores Other subject-reported health outcomes. [ Time Frame: Up to 52 Weeks ]
  • Incidence and severity of adverse events. [ Time Frame: Up to 52 Weeks ]
  • Changes in vital signs (blood pressure and pulse) and weight. [ Time Frame: Up to 52 Weeks ]
  • Changes in laboratory assessments (hematology and clinical chemistry). [ Time Frame: Up to 52 Weeks ]
  • Changes in electrocardiogram (ECG) parameters. [ Time Frame: Up to 52 Weeks ]
  • Assessment of augmentation. [ Time Frame: Up to 52 Weeks ]
  • Assessment of rebound. [ Time Frame: Up to 52 Weeks ]
  • Change from baseline in the IRLS Rating Scale total score at Week 52 LOCF (last observation carried forward). [ Time Frame: Up to 52 Weeks ]
  • Proportion of subjects with a score of much improved (2) or very much improved (1) on CGI-I at Week 52 LOCF. [ Time Frame: Up to 52 Weeks ]
  • CGI Severity of Illness (CGI-S) at Week 52 LOCF. [ Time Frame: Up to 52 Weeks ]
  • Change from baseline in the domains of the Medical Outcomes Study (MOS-12) Sleep Scale at Week 52 LOCF. [ Time Frame: Up to 52 Weeks ]
  • Change from baseline in the overall life impact score of the RLS Quality of Life Questionnaire at Week 52 LOCF. [ Time Frame: Up to 52 Weeks ]
  • Change from baseline in the anxiety and depression domains of the Hospital Anxiety and Depression (HADS) Scale at Week 52 LOCF. [ Time Frame: Up to 52 Weeks ]
  • Change from baseline in the total score and domains of the Profile of Mood States (POMS) Scale Short Form at Week 52 LOCF. [ Time Frame: Up to 52 Weeks ]
  • Change from baseline in the parameters for the work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) Questionnaire at Week 52 LOCF. [ Time Frame: Up to 52 Weeks ]
  • Proportion of subjects satisfied with their treatment at Week 52 LOCF. [ Time Frame: Up to 52 Weeks ]


Original Secondary Outcome:

  • Change from baseline in IRLS Rating Scale total score
  • CGI Scale scores
  • Medical Outcomes Study Sleep Scale scores
  • Other subject-reported health outcomes.


Information By: GlaxoSmithKline

Dates:
Date Received: July 20, 2006
Date Started: October 2005
Date Completion:
Last Updated: October 27, 2016
Last Verified: October 2016