Clinical trial NCT00650104: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: ropinirole IR
efficacy
safety
open-label
long term safety; REQUIP
ropinirole XL
ropinirole CR
Parkinson's disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 76
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
timeFrame: Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78
measure: Number of Participants With the Indicated Number of Adverse Events (AEs)
timeFrame: Every study visit from baseline to market availability (Month 78)
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
timeFrame: Screening; Months 3, 9, 15, 27, and 78
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)
timeFrame: Screening; Months 3, 9, 15, 27, and 78
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)
timeFrame: Screening and Month 78
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)
timeFrame: Screening and Month 78
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)
timeFrame: Screening and Month 78
measure: Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
timeFrame: Week 2, Month 12, Month 78
measure: Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
timeFrame: Week 2, Month 12, Month 78
measure: Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
timeFrame: Week 2, Month 12, Month 78
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Oxnard
country: United States
facility: GSK Investigational Site
state: California
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Edison
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Upland
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hauser RA, Reichmann H, Lew M, Asgharian A, Makumi C, Shulman KJ. Long-term, open-label study of once-daily ropinirole prolonged release in early Parkinson's disease. Int J Neurosci. 2011 May;121(5):246-53. doi: 10.3109/00207454.2010.546538. Epub 2011 Jan 19.