Protocol Summary for 101468/228
| Protocol Id: | 101468/228 |
| Secondary Ids: |
|
| Title: | A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. |
| 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: | 0054 |
| Has Expanded Access?: | |
| Study Type: | Interventional |
| Oversight Authority: |
|
| Collaborators: |
|
| Brief Summary: | This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years. |
| Detailed Description: | |
| Record Verification Date: | June 2012 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | December 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: |
|
| Secondary Outcomes: |
|
| Conditions: |
|
| Keywords: |
|
| Eligibility Criteria: | 
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 30 Year |
| Maximum Age: | 70 Year |
| Enrollment: | 350 |
| 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
|