Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528

A Phase 3 study testing Requip PR in people with Parkinson Disease, run by GlaxoSmithKline at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Requip PR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 295 participants
Where: 18 sitesChina
Study dates: 2 Sep 2010to 28 Mar 2012
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

Subjects must have completed 24 weeks of randomised treatment in study ROP111528(and must have completed the one-week downtitration at the end of treatment/early withdrawal).
Subjects must not have a break in medication between completing the downtitration phase for studies ROP111528 and beginning treatment in this extension study.
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

Patients with any ongoing clinically significant adverse events at the end of the study ROP111528.
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 study ROP111528.
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 CYP1A2 (e.g. ciprofloxacine, 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

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

China18 sites

GSK Investigational Site
Beijing, 100034
GSK Investigational Site
Beijing, 100050
GSK Investigational Site
Beijing, 100053
GSK Investigational Site
Beijing, 100730
GSK Investigational Site
Beijing, 100853
GSK Investigational Site
Chengdu, Sichuan, 610041
GSK Investigational Site
Chengdu, Sichuan, 610072
GSK Investigational Site
Guangzhou, Guangdong, 510120
GSK Investigational Site
Hangzhou, Zhejiang, 310009
GSK Investigational Site
Kunming, Yunnan, 650032
GSK Investigational Site
Kunming, Yunnan, 650101
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Shanghai, 200032
GSK Investigational Site
Shanghai, 200040
GSK Investigational Site
Suzhou, Jiangsu, 215004
GSK Investigational Site
Tianjin, 300052
GSK Investigational Site
Wuhan, Hubei, 430022
GSK Investigational Site
Xi'an, Shaanxi, 710061

Other trials in China

About this study

Official title: An Open Label Extension Study With REQUIP PR for Subjects From Study ROP111528

This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.

Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.

Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.

Conditions: Parkinson Disease
Being tested: Requip PR
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Requip PRDrug
Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control.

Study groups in NCT01536574
Study group	Role	What they receive
Requip PR	Experimental	Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg Receives: Drug: Requip PR

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase)
AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.
Measured: From the start of treatment (Baseline) up to Week 25
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase
An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase.
Measured: From the start of treatment (Baseline) up to Week 25
Number of Participants With an Adverse Event During the Follow-up Phase
AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.
Measured: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)
Number of Participants With the Indicated Adverse Events During the Follow-up Phase
An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.
Measured: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase
An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.
Measured: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)

Secondary outcomes (2)

Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24
The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe.
Measured: Week 24
Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24
The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 201028 Mar 2012

First posted22 Feb 2012 (estimated)
Study start2 Sep 2010
Primary completion1 Mar 2012
Study completion28 Mar 2012

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 295 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01536574
Sponsor's protocol ID: 114463
Status last verified: Jun 2018
First submitted: 19 Jan 2012
Last updated: 13 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zhang Z, Wang J, Zhang X, Chen S, Wang Z, Zhang B, Liu C, Qu Q, Cheng Y, Zhu R, Li J, Hu J, Cai M. An open-label extension study to evaluate the safety of ropinirole prolonged release in Chinese patients with advanced Parkinson's disease. Curr Med Res Opin. 2015 Apr;31(4):723-30. doi: 10.1185/03007995.2015.1005835. Epub 2015 Mar 12.
PubMed 25586298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Extension Study With REQUIP PR for Subjects From Study ROP111528
ClinicalTrials.gov ID: NCT01536574
Acronym / sponsor ID: 114463
Conditions: Parkinson Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 295 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 2 Sep 2010
Primary completion: 1 Mar 2012 (actual)
Study completion: 28 Mar 2012 (actual)
First posted: 22 Feb 2012 (estimated)
Results: Posted 13 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.

Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Requip PR	Experimental	Drug: Requip PRRopinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects must have completed 24 weeks of randomised treatment in study ROP111528(and must have completed the one-week downtitration at the end of treatment/early withdrawal).
Subjects must not have a break in medication between completing the downtitration phase for studies ROP111528 and beginning treatment in this extension study.
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.

Key exclusion criteria (7 listed)

Patients with any ongoing clinically significant adverse events at the end of the study ROP111528.
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 study ROP111528.
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 CYP1A2 (e.g. ciprofloxacine, 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.

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
Requip PREligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control.	Drug	Requip PR

Primary outcome

Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase)
Time frame: From the start of treatment (Baseline) up to Week 25
AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase
Time frame: From the start of treatment (Baseline) up to Week 25
An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase.
Number of Participants With an Adverse Event During the Follow-up Phase
Time frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)
AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.
Number of Participants With the Indicated Adverse Events During the Follow-up Phase
Time frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)
An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase
Time frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)
An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.

2 secondary outcomes

Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24
Time frame: Week 24
Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 13 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study	162	156
Placebo in Parent DB Study, Ropinirole PR in OL Study	133	126

Primary outcome: Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase)

Time frame: From the start of treatment (Baseline) up to Week 25. Number. Unit: Participants

Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n = 162	Placebo in Parent DB Study, Ropinirole PR in OL Study n = 133
Any AE	58	56
AE Related to Investigational Product (IP)	33	35
Any SAE	2	4
SAE Related to Investigational Product (IP)	0	1
AE Leading to Death	0	0
AE Leading to Withdrawal	4	4

Population analysed: Safety Population: all participants who received at least one dose of study drug

Primary outcome: Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase

Time frame: From the start of treatment (Baseline) up to Week 25. Number. Unit: Participants

Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n = 162	Placebo in Parent DB Study, Ropinirole PR in OL Study n = 133
Dyskinesia	6	10
Dizziness	5	3
Somnolence	0	6
Akathisia	0	1
Akinesia	1	0
Cerebral infarction	1	0
Headache	0	1
Lethargy	0	1

Population analysed: Safety Population

Primary outcome: Number of Participants With an Adverse Event During the Follow-up Phase

Time frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27). Number. Unit: Participants

Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n = 162	Placebo in Parent DB Study, Ropinirole PR in OL Study n = 133
Any AE	2	3
AE related to IP	1	2
Any SAE	0	0

Population analysed: Safety Population

Primary outcome: Number of Participants With the Indicated Adverse Events During the Follow-up Phase

Time frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27). Number. Unit: Participants

Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n = 162	Placebo in Parent DB Study, Ropinirole PR in OL Study n = 133
Facial palsy	0	1
Parkinsonian rest tremor	0	1
Lymphopenia	1	0
Hallucination	0	1
Choking sensation	1	0

Population analysed: Safety Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs are presented for the On-treatment Phase, including the Open-label Treatment Phase (24 weeks) and the Down-titration Phase (1 week) (up to Study Week 25).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study	2 of 162 (1.2%)	58 of 162 (35.8%)	Not reported
Placebo in Parent DB Study, Ropinirole PR in OL Study	4 of 133 (3%)	56 of 133 (42.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25586298Zhang Z, Wang J, Zhang X, Chen S, Wang Z, Zhang B, Liu C, Qu Q, Cheng Y, Zhu R, Li J, Hu J, Cai M. An open-label extension study to evaluate the safety of ropinirole prolonged release in Chinese patients with advanced Parkinson's disease. Curr Med Res Opin. 2015 Apr;31(4):723-30. doi: 10.1185/03007995.2015.1005835. Epub 2015 Mar 12.

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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

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Requip PR in people with Parkinson Disease, run by GlaxoSmithKline at 18 sites in China.

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 5 inclusion and 7 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. 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 13 Dec 2012). 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 Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) (time frame: From the start of treatment (Baseline) up to Week 25). The study lists 5 primary outcomes in all. 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 NCT01536574, 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 13 Aug 2018.