An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease

Parkinson Disease Clinical Trial

Official title:

An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632736
• Other study ID #: 101468/248
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2008
• Last updated: March 21, 2017
• Start date: February 2004
• Est. completion date: March 2010

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Ropinirole XL (formerly CR)

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Hasselt
Belgium	GSK Investigational Site	Hoboken
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Roeselare
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Hradec Kralove
Czech Republic	GSK Investigational Site	Ostrava
Czech Republic	GSK Investigational Site	Ostrava 10
Czech Republic	GSK Investigational Site	Pardubice
Czech Republic	GSK Investigational Site	Plzen - Lochotin
Czech Republic	GSK Investigational Site	Prague
Czech Republic	GSK Investigational Site	Praha 2
France	GSK Investigational Site	Aix en Provence
France	GSK Investigational Site	Lille Cedex
France	GSK Investigational Site	Rouffach
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Pécs
Hungary	GSK Investigational Site	Vasvari Pal street 2, H=9023 Gyor
Italy	GSK Investigational Site	Grosseto	Toscana
Italy	GSK Investigational Site	Lido Di Camaiore (LU)	Toscana
Italy	GSK Investigational Site	Pescara	Abruzzo
Italy	GSK Investigational Site	Pozzilli (IS)	Molise
Italy	GSK Investigational Site	Vicenza	Veneto
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Ciborz
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Leszno
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Torun
Poland	GSK Investigational Site	Warsaw
Poland	GSK Investigational Site	Warszawa
Spain	GSK Investigational Site	Barcelona
United Kingdom	GSK Investigational Site	Blackpool	Lancashire
United Kingdom	GSK Investigational Site	Chertsey	Surrey
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Newcastle Upon Tyne	Northumberland
United Kingdom	GSK Investigational Site	Swansea
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Bingham Farms	Michigan
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boca Raton	Florida
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Glenview	Illinois
United States	GSK Investigational Site	Kansas City	Kansas
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Panama City	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Port Orange	Florida
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Southfield	Michigan
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Traverse City	Michigan
United States	GSK Investigational Site	Upland	Pennsylvania
United States	GSK Investigational Site	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  France,  Hungary,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.	13 February 2004 through 31 March 2010
Secondary	Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26	The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: "Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day." Wk, Week.	Week 4 and Week 26

External Links

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