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Home > Protocol Summaries: Compounds > ropinirole > Protocol Summary for 101468/169

Protocol Summary for 101468/169

Protocol Summary
Protocol Id: 101468/169
Secondary Ids:
Title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa
Phase: phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 60,503
IND/IDE Serial Number: 0046
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
Brief Summary: The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.
Detailed Description:
Record Verification Date: June 2012
Status: Completed
Why Study Stopped:
Study Start Date: June 2003
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
Secondary Outcomes:
  • Mean change from baseline in:
  • UPDRS Activities of Daily Living score
  • Unified Parkinson's Disease Rating Scale (UPDRS) total motor score
  • amount and percent of awake time spent "on"
  • percent awake time spent "off"
Conditions:
  • Parkinson Disease
Keywords:
  • Parkinson's Disease
  • Dyskinesia
  • Adjunctive Therapy with L-dopa
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 30 Year
Maximum Age:
Enrollment: 393
Enrollment Type:
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