Long-Term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: Ropinirole XL (formerly CR) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official 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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Safety and tolerability are assessed by monitoring AEs, concomitant medications, orthostatic blood pressure/pulse, ECGs, and physical examinations.
Secondary outcome: 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).
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or non-pregnant/non-breast feeding females
- At least 30 years of age
- Diagnosis of idiopathic Parkinson''s disease (Hoehn & Yahr criteria)
- Completed either Study 167 or Study 164
Exclusion Criteria:
- Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological,
neurological, cardiovascular disease or active malignancy
- Dizziness or fainting due to orthostatic hypotension on standing
- Significant sleep disorder
- Drug abuse or alcoholism
Locations and Contacts
GSK Clinical Trials Call Centre, Hasselt 3500, Belgium
GSK Clinical Trials Call Centre, Roeselare B-8800, Belgium
GSK Clinical Trials Call Centre, Toulouse 31059, France
GSK Clinical Trials Call Centre, Heerlen 6419 PC, Netherlands
GSK Clinical Trials Call Centre, Fredrikstad N-1603, Norway
GSK Clinical Trials Call Center, Scottsdale, Arizona 85259, United States
GSK Clinical Trials Call Center, Little Rock, Arkansas 72205, United States
GSK Clinical Trials Call Center, Los Angeles, California 90033, United States
GSK Clinical Trials Call Center, Oxnard, California 93030, United States
GSK Clinical Trials Call Center, Miami, Florida 33136, United States
GSK Clinical Trials Call Center, Tampa, Florida 33606, United States
GSK Clinical Trials Call Center, Augusta, Georgia 30912, United States
GSK Clinical Trials Call Center, Kansas City, Kansas 66160, United States
GSK Clinical Trials Call Center, Edison, New Jersey 08818, United States
GSK Clinical Trials Call Center, Upland, Pennsylvania 19013, United States
GSK Clinical Trials Call Center, Houston, Texas 77030, United States
Additional Information
Starting date: May 2002
Ending date: December 2008
Last updated: March 31, 2008
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