Clinical trial NCT00632736: An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease
Official title: An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Parkinson's Disease
Keywords: ropinirole XL
REQUIP
Parkinson's disease
long term safety
efficacy
safety
ropinirole CR
ropinirole IR
open-label
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-03-11
Enrollment: 419
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: To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease


Eligibility criteria: Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

* Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down titration at the end of treatment/early withdrawal).
* Subjects must not have a break in medication between completing the feeder study (including the down titration phase for studies 168 and 169) and beginning treatment in study 248.
* Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System).
* Provide written informed consent for this study.
* Be willing and able to comply with study procedures.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

* Patients with any ongoing clinically significant adverse events at the end of the "feeder" studies.
* Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma).
* Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the feeder study (REQUIP study 165, 168 or 169).
* Subjects with severe dizziness or fainting due to postural hypotension on standing.
* Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit cytochrome P 450 1A2 (CYP1A2 \[e.g. ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol\]) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
* Women who are pregnant or breast-feeding.
* Use of an investigational drug throughout the treatment period.

Primary outcomes:
measure: Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 13 February 2004 through 31 March 2010
Secondary outcomes:
measure: Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
timeFrame: Week 4 and Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Englewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Panama City
country: United States
facility: GSK Investigational Site
state: Florida
city: Port Orange
country: United States
facility: GSK Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Glenview
country: United States
facility: GSK Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Bingham Farms
country: United States
facility: GSK Investigational Site
state: Michigan
city: Southfield
country: United States
facility: GSK Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: GSK Investigational Site
state: Michigan
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Upland
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: GSK Investigational Site
state: Texas
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Hasselt
country: Belgium
facility: GSK Investigational Site
city: Hoboken
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Roeselare
country: Belgium
facility: GSK Investigational Site
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: GSK Investigational Site
city: Ostrava 10
country: Czech Republic
facility: GSK Investigational Site
city: Ostrava
country: Czech Republic
facility: GSK Investigational Site
city: Pardubice
country: Czech Republic
facility: GSK Investigational Site
city: Plzen - Lochotin
country: Czech Republic
facility: GSK Investigational Site
city: Prague
country: Czech Republic
facility: GSK Investigational Site
city: Praha 2
country: Czech Republic
facility: GSK Investigational Site
city: Aix en Provence
country: France
facility: GSK Investigational Site
city: Lille Cedex
country: France
facility: GSK Investigational Site
city: Rouffach
country: France
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Pécs
country: Hungary
facility: GSK Investigational Site
city: Vasvari Pal street 2, H=9023 Gyor
country: Hungary
facility: GSK Investigational Site
city: Pescara
country: Italy
facility: GSK Investigational Site
state: Abruzzo
city: Pozzilli (IS)
country: Italy
facility: GSK Investigational Site
state: Molise
city: Grosseto
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Lido Di Camaiore (LU)
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Vicenza
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Ciborz
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Leszno
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Warsaw
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Newcastle Upon Tyne
country: United Kingdom
facility: GSK Investigational Site
state: Northumberland
city: Chertsey
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
city: Swansea
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Makumi CW, Asgharian A, Ellis J, Shaikh S, Jimenez T, VanMeter S. Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease. Int J Neurosci. 2016;126(1):30-8. doi: 10.3109/00207454.2014.991924. Epub 2014 Dec 27.