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

NCT00632736 | Completed Phase 3 Results

• 1 other identifier: 101468/248
• Study Type: interventional
• Target: 419
• Locations: 9 countries
• Sites: 75

Brief Summary

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

Conditions

Parkinson Disease; Parkinson's Disease

Keywords

ropinirole XL; REQUIP; Parkinson's disease; long term safety; efficacy; safety; ropinirole CR; ropinirole IR; open-label

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26

  Week 4 and Week 26

Study Arms (1)

Ropinirole XL (formerly CR)

ACTIVE COMPARATOR

Ropinirole XL (formerly CR)

Drug: Ropinirole XL (formerly CR)

Interventions

Ropinirole XL (formerly CR) DRUG

Ropinirole XL (formerly CR)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (75)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

Location

GSK Investigational Site

Fountain Valley, California, 92708, United States

Location

GSK Investigational Site

San Francisco, California, 94109, United States

Location

GSK Investigational Site

Englewood, Colorado, 80110, United States

Location

GSK Investigational Site

Boca Raton, Florida, 33486, United States

Location

GSK Investigational Site

Panama City, Florida, 32405, United States

Location

GSK Investigational Site

Port Orange, Florida, 32127, United States

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GSK Investigational Site

St. Petersburg, Florida, 33701, United States

Location

GSK Investigational Site

Tampa, Florida, 33606, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Augusta, Georgia, 30912, United States

Location

GSK Investigational Site

Glenview, Illinois, 60025, United States

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GSK Investigational Site

Kansas City, Kansas, 66160, United States

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GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Bingham Farms, Michigan, 48025, United States

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GSK Investigational Site

Southfield, Michigan, 48034, United States

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GSK Investigational Site

Traverse City, Michigan, 49684, United States

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GSK Investigational Site

Albany, New York, 12205, United States

Location

GSK Investigational Site

Durham, North Carolina, 27705, United States

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GSK Investigational Site

Toledo, Ohio, 43614-5809, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

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GSK Investigational Site

Upland, Pennsylvania, 19013, United States

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GSK Investigational Site

San Antonio, Texas, 78229, United States

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GSK Investigational Site

Wichita Falls, Texas, 76301, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53233, United States

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Hasselt, 3500, Belgium

Location

GSK Investigational Site

Hoboken, 2660, Belgium

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Roeselare, 8800, Belgium

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GSK Investigational Site

Brno, 656 91, Czechia

Location

GSK Investigational Site

Hradec Králové, 500 05, Czechia

Location

GSK Investigational Site

Ostrava, 703 52, Czechia

Location

GSK Investigational Site

Ostrava, 710 00, Czechia

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GSK Investigational Site

Pardubice, 535 03, Czechia

Location

GSK Investigational Site

Plzen - Lochotin, 304 60, Czechia

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GSK Investigational Site

Prague, 100 34, Czechia

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GSK Investigational Site

Prague, 120 00, Czechia

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GSK Investigational Site

Aix-en-Provence, 13616, France

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GSK Investigational Site

Lille, 59037, France

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GSK Investigational Site

Rouffach, 68250, France

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GSK Investigational Site

Budapest, 1083, Hungary

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GSK Investigational Site

Budapest, 1096, Hungary

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GSK Investigational Site

Budapest, 1135, Hungary

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GSK Investigational Site

Budapest, 1145, Hungary

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GSK Investigational Site

Budapest, 1204, Hungary

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GSK Investigational Site

Debrecen, H-4012, Hungary

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GSK Investigational Site

Miskolc, 3526, Hungary

Location

GSK Investigational Site

Miskolc, 3529, Hungary

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GSK Investigational Site

Pécs, 7623, Hungary

Location

GSK Investigational Site

Vasvari Pal Street 2, H=9023 Gyor, Hungary

Location

GSK Investigational Site

Pescara, Abruzzo, 65100, Italy

Location

GSK Investigational Site

Pozzilli (IS), Molise, 86077, Italy

Location

GSK Investigational Site

Grosseto, Tuscany, 58100, Italy

Location

GSK Investigational Site

Lido Di Camaiore (LU), Tuscany, 55043, Italy

Location

GSK Investigational Site

Vicenza, Veneto, 36057, Italy

Location

GSK Investigational Site

Bialystok, 15-276, Poland

Location

GSK Investigational Site

Cibórz, 66-212, Poland

Location

GSK Investigational Site

Gdansk, 80-211, Poland

Location

GSK Investigational Site

Gdansk, 80-299, Poland

Location

GSK Investigational Site

Katowice, 40-752, Poland

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GSK Investigational Site

Krakow, 31-530, Poland

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GSK Investigational Site

Leszno, 64-100, Poland

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GSK Investigational Site

Lublin, 20-718, Poland

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GSK Investigational Site

Lublin, 20-954, Poland

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GSK Investigational Site

Poznan, 61-285, Poland

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GSK Investigational Site

Torun, 87-100, Poland

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GSK Investigational Site

Warsaw, 01-337, Poland

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GSK Investigational Site

Warsaw, 02-097, Poland

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GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Glasgow, Lanarkshire, G51 4TF, United Kingdom

Location

GSK Investigational Site

Blackpool, Lancashire, FY3 8BP, United Kingdom

Location

GSK Investigational Site

Newcastle upon Tyne, Northumberland, NE4 6BE, United Kingdom

Location

GSK Investigational Site

Chertsey, Surrey, KT16 0QA, United Kingdom

Location

GSK Investigational Site

Swansea, SA6 6NL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25495896 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 11, 2008
• Study Start: February 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 23, 2017
• Results First Posted: December 24, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (25); IT (5); BE (5); HU (10); PL (13); ES (1); GB (5); CZ (8); FR (3)