Last updated: 11/07/2018 07:45:33
Open-Label Extension Study with REQUIP PR for Subjects from Study ROP111528
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open Label Extension Study with REQUIP PR for subjects from study ROP111528
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
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
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
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)
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)
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:
Mean Gambling Symptom Assessment Scale (G-SAS) score at Week 24
Timeframe: Week 24
Mean change from Baseline in the Gambling Symptom Assessment Scale (G-SAS) score at Week 24
Timeframe: Baseline and Week 24
Interventions:
Drug: Requip PR
Enrollment:
295
Observational study model:
Not applicable
Primary completion date:
2012-28-03
Time perspective:
Not applicable
Clinical publications:
Zhenxin ZHANG, Jian WANG, Xiaoying ZHANG, Shengdi CHEN, Zhenfu WANG, Baorong ZHANG, Chunfeng LIU, Qiumin QU, Yan CHENG, Rongxuan Zhu, Jie Li, Jingqiu Hu, Meng Cai.An open-label extension study to evaluate safety of ropinirole prolonged-release in Chinese patients with advanced Parkinson’s disease.Curr Med Res Opin.2015;31(4):723-730
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
September 2010 to March 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
30+ years
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-28-03
Actual study completion date
2012-28-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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