Clinical trial NCT01536574: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 295
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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).
2. Subjects must not have a break in medication between completing the downtitration phase for studies ROP111528 and beginning treatment in this extension study.
3. 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).
4. Provide written informed consent for this study.
5. Be willing and able to comply with study procedures.

Exclusion Criteria:

1. Patients with any ongoing clinically significant adverse events at the end of the study ROP111528.
2. 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).
3. Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the study ROP111528.
4. Subjects with severe dizziness or fainting due to postural hypotension on standing.
5. 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.
6. Women who are pregnant or breast-feeding.
7. Use of an investigational drug throughout the treatment period.

Primary outcomes:
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)
timeFrame: From the start of treatment (Baseline) up to Week 25
measure: Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase
timeFrame: From the start of treatment (Baseline) up to Week 25
measure: Number of Participants With an Adverse Event During the Follow-up Phase
timeFrame: 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)
measure: Number of Participants With the Indicated Adverse Events During the Follow-up Phase
timeFrame: 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)
measure: Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase
timeFrame: 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:
measure: Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24
timeFrame: Week 24
measure: Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: GSK Investigational Site
state: Guangdong
city: Wuhan
country: China
facility: GSK Investigational Site
state: Hubei
city: Suzhou
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Xian
country: China
facility: GSK Investigational Site
state: Shaanxi
city: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
city: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
city: Kunming
country: China
facility: GSK Investigational Site
state: Yunnan
city: Kunming
country: China
facility: GSK Investigational Site
state: Yunnan
city: Hangzhou
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.