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Home > Protocol Summaries: Compounds > ropinirole > Protocol Summary for 101468/196

Protocol Summary for 101468/196

Protocol Summary
Protocol Id: 101468/196
Secondary Ids:
  • N/A
Title: 101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164
Phase: phase 3
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 60,503
IND/IDE Serial Number: 0020
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • France: Afssaps - French Health Products Safety Agency
  • United States: Food and Drug Administration
  • Belgium: Federal Agency for Medicinal Products and Health Products
  • Netherlands: Medicines Evaluation Board (MEB)
  • Norway: Norwegian Medicines Agency
Collaborators:
  • N/A
Brief Summary: The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.
Detailed Description:
Record Verification Date: April 2013
Status: Completed
Why Study Stopped:
Study Start Date: May 2002
Study Completion Date: March 2009
Study Completion Date Type: Actual
Primary Completion Date: March 2009
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Non-randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Safety and tolerability are assessed by monitoring AEs, concomitant medications, orthostatic blood pressure/pulse, ECGs, and physical examinations. yes Every 3 months until end of study.
Secondary Outcomes:
  • Efficacy is assessed using Clinical Global Impression (Part 1 and 2; for the first year of the study only) and the Unified Parkinson’s Disease Rating Scale (UPDRS) (Part II and III). Every 3 months until end of study.
Conditions:
  • Parkinson Disease
Keywords:
  • ropinirole IR
  • efficacy
  • safety
  • open-label
  • long term safety; REQUIP
  • ropinirole XL
  • ropinirole CR
  • Parkinson's disease
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 30 Year
Maximum Age:
Enrollment: 76
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information