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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Requip PR

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Requip PR

Arm Description

Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01536574

First Posted

January 19, 2012

Last Updated

June 18, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01536574

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

September 2, 2010 (undefined)

Primary Completion Date

March 1, 2012 (Actual)

Study Completion Date

March 28, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

295 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Requip PR

Arm Type

Experimental

Arm Description

Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg

Intervention Type

Drug

Intervention Name(s)

Requip PR

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Description

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.

Time Frame

From the start of treatment (Baseline) up to Week 25

Title

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

Description

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.

Time Frame

From the start of treatment (Baseline) up to Week 25

Title

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

Description

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.

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)

Title

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

Description

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.

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)

Title

Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase

Description

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.

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)

Secondary Outcome Measure Information:

Title

Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24

Description

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.

Time Frame

Week 24

Title

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

Description

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.

Time Frame

Baseline and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

GSK Investigational Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Facility Name

GSK Investigational Site

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215004

Country

China

Facility Name

GSK Investigational Site

City

Xian

State/Province

Shaanxi

ZIP/Postal Code

710061

Country

China

Facility Name

GSK Investigational Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

GSK Investigational Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610072

Country

China

Facility Name

GSK Investigational Site

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650032

Country

China

Facility Name

GSK Investigational Site

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650101

Country

China

Facility Name

GSK Investigational Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100053

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

GSK Investigational Site

City

Tianjin

ZIP/Postal Code

300052

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25586298

Citation

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.

Results Reference

derived

Parkinson Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial