Parkinson DiseasePhase 3NCT00632736
An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease
A Phase 3 study testing Ropinirole XL (formerly CR) in people with Parkinson Disease and Parkinson's Disease, run by GlaxoSmithKline at 75 sites in 9 countries.
Trial summary
To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease, Parkinson's Disease
- What is being tested?
- Ropinirole XL (formerly CR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 75 sitesin 9 countries
- Study dates
- Feb 2004to Mar 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
75 sites in 9 countries.
75 sites in 9 countries
United States25 sites
GSK Investigational Site
Albany, New York, 12205
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Bingham Farms, Michigan, 48025
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Boca Raton, Florida, 33486
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Durham, North Carolina, 27705
GSK Investigational Site
Englewood, Colorado, 80110
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Glenview, Illinois, 60025
GSK Investigational Site
Kansas City, Kansas, 66160
GSK Investigational Site
Milwaukee, Wisconsin, 53233
GSK Investigational Site
Panama City, Florida, 32405
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Port Orange, Florida, 32127
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Francisco, California, 94109
GSK Investigational Site
Southfield, Michigan, 48034
GSK Investigational Site
St. Petersburg, Florida, 33701
GSK Investigational Site
Tampa, Florida, 33606
GSK Investigational Site
Toledo, Ohio, 43614-5809
GSK Investigational Site
Traverse City, Michigan, 49684
GSK Investigational Site
Upland, Pennsylvania, 19013
GSK Investigational Site
Wichita Falls, Texas, 76301
Poland13 sites
GSK Investigational Site
Bialystok, 15-276
GSK Investigational Site
Cibórz, 66-212
GSK Investigational Site
Gdansk, 80-211
GSK Investigational Site
Gdansk, 80-299
GSK Investigational Site
Katowice, 40-752
GSK Investigational Site
Krakow, 31-530
GSK Investigational Site
Leszno, 64-100
GSK Investigational Site
Lublin, 20-718
GSK Investigational Site
Lublin, 20-954
GSK Investigational Site
Poznan, 61-285
GSK Investigational Site
Torun, 87-100
GSK Investigational Site
Warsaw, 01-337
GSK Investigational Site
Warsaw, 02-097
Hungary10 sites
GSK Investigational Site
Budapest, 1083
GSK Investigational Site
Budapest, 1096
GSK Investigational Site
Budapest, 1135
GSK Investigational Site
Budapest, 1145
GSK Investigational Site
Budapest, 1204
GSK Investigational Site
Debrecen, H-4012
GSK Investigational Site
Miskolc, 3526
GSK Investigational Site
Miskolc, 3529
GSK Investigational Site
Pécs, 7623
GSK Investigational Site
Vasvari Pal Street 2, H=9023 Gyor
Czechia8 sites
GSK Investigational Site
Brno, 656 91
GSK Investigational Site
Hradec Králové, 500 05
GSK Investigational Site
Ostrava, 703 52
GSK Investigational Site
Ostrava, 710 00
GSK Investigational Site
Pardubice, 535 03
GSK Investigational Site
Plzen - Lochotin, 304 60
GSK Investigational Site
Prague, 100 34
GSK Investigational Site
Prague, 120 00
Belgium5 sites
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Hasselt, 3500
GSK Investigational Site
Hoboken, 2660
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Roeselare, 8800
Italy5 sites
GSK Investigational Site
Grosseto, Tuscany, 58100
GSK Investigational Site
Lido Di Camaiore (LU), Tuscany, 55043
GSK Investigational Site
Pescara, Abruzzo, 65100
GSK Investigational Site
Pozzilli (IS), Molise, 86077
GSK Investigational Site
Vicenza, Veneto, 36057
United Kingdom5 sites
GSK Investigational Site
Blackpool, Lancashire, FY3 8BP
GSK Investigational Site
Chertsey, Surrey, KT16 0QA
GSK Investigational Site
Glasgow, Lanarkshire, G51 4TF
GSK Investigational Site
Newcastle upon Tyne, Northumberland, NE4 6BE
GSK Investigational Site
Swansea, SA6 6NL
France3 sites
GSK Investigational Site
Aix-en-Provence, 13616
GSK Investigational Site
Lille, 59037
GSK Investigational Site
Rouffach, 68250
About this study
Official title: An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169
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
- Being tested
- Ropinirole XL (formerly CR)
- Keywords
- ropinirole XL, REQUIP, Parkinson's disease, long term safety, efficacy, safety, ropinirole CR, ropinirole IR, open-label
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropinirole XL (formerly CR)Drug
| Study group | Role | What they receive |
|---|---|---|
| Ropinirole XL (formerly CR) | Active comparator | Ropinirole XL (formerly CR) Receives: Drug: Ropinirole XL (formerly CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Week 4 and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startFeb 2004
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632736
- Sponsor's protocol ID
- 101468/248
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2008
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 25495896
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169
- ClinicalTrials.gov ID
- NCT00632736
- Acronym / sponsor ID
- 101468/248
- Conditions
- Parkinson Disease, Parkinson's Disease
- Keywords
- ropinirole XL, REQUIP, Parkinson's disease, long term safety, efficacy, safety, ropinirole CR, ropinirole IR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Posted 24 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ropinirole XL (formerly CR) | Active comparator | Drug: Ropinirole XL (formerly CR)Ropinirole XL (formerly CR) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropinirole XL (formerly CR) | Drug | Ropinirole XL (formerly CR) |
Primary outcome
Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 13 February 2004 through 31 March 2010
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.
1 secondary outcome
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Time frame: Week 4 and Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25495896Makumi 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
75 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropinirole XL (formerly CR) in people with Parkinson Disease and Parkinson's Disease, run by GlaxoSmithKline at 75 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Poland, Hungary, Czechia, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 13 February 2004 through 31 March 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.