Parkinson Disease
Conditions
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.
Interventions
DRUGRequip PR
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | 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 the Indicated Adverse Events During the Follow-up Phase | 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 | 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. |
| 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) | 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 an Adverse Event During the Follow-up Phase | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | Baseline and 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. |
| Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | 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. |
Countries
China
Participant flow
Pre-assignment details
Participants who completed 24 weeks of randomized treatment in parent Study ROP111528 (NCT01154166) and 1 week of down titration at the end of treatment or at early withdraw were allowed to enter this extension study provided they had continued on study drug without a break.
Participants by arm
| Arm | Count |
|---|---|
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. | 162 |
| Placebo in Parent DB Study, Ropinirole PR in OL Study Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR. | 133 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 5 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Placebo in Parent DB Study, Ropinirole PR in OL Study | Total |
|---|---|---|---|
| Age, Continuous | 64.5 Years STANDARD_DEVIATION 9.1 | 63.9 Years STANDARD_DEVIATION 9.87 | 64.2 Years STANDARD_DEVIATION 9.44 |
| Duration of Parkinson's Disease | 96.8 months STANDARD_DEVIATION 59.68 | 105.3 months STANDARD_DEVIATION 49.61 | 100.7 months STANDARD_DEVIATION 55.44 |
| Race/Ethnicity, Customized Oriental | 162 participants | 133 participants | 295 participants |
| Sex: Female, Male Female | 51 Participants | 53 Participants | 104 Participants |
| Sex: Female, Male Male | 111 Participants | 80 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 58 / 162 | 56 / 133 |
| serious Total, serious adverse events | 2 / 162 | 4 / 133 |
Outcome results
Primary
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.
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)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With an Adverse Event During the Follow-up Phase | Any AE | 2 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With an Adverse Event During the Follow-up Phase | AE related to IP | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With an Adverse Event During the Follow-up Phase | Any SAE | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With an Adverse Event During the Follow-up Phase | Any AE | 3 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With an Adverse Event During the Follow-up Phase | AE related to IP | 2 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With an Adverse Event During the Follow-up Phase | Any SAE | 0 Participants |
Primary
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.
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)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Parkinsonian rest tremor | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Hallucination | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Lymphopenia | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Choking sensation | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Facial palsy | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Choking sensation | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Facial palsy | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Parkinsonian rest tremor | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Lymphopenia | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | Hallucination | 1 Participants |
Primary
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.
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)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | Lymphopenia | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | Parkinsonian rest tremor | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | Hallucination | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | Lymphopenia | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | Parkinsonian rest tremor | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | Hallucination | 1 Participants |
Primary
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.
Time frame: From the start of treatment (Baseline) up to Week 25
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Nausea | 4 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Hallucination, auditory | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Cerebral infarction | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Impulse-control disorder | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Constipation | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Oedema peripheral | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Akathisia | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Gait disturbance | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Abdominal distension | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Medication residue | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Headache | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Orthostatic hypotension | 2 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Abdominal pain upper | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Hypotension | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Somnolence | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Lymphopenia | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Epigastric discomfort | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Arrhythmia | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Lethargy | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Blood uric acid increased | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Flatulence | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Weight decreased | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Akinesia | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Muscle spasms | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Vomiting | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Musculoskeletal stiffness | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Syncope | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Vertigo | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Hallucination | 5 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Decreased appetite | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Dizziness | 5 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Asphyxia | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Insomnia | 1 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Pruritus | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Dyskinesia | 6 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Pruritus | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Dyskinesia | 10 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Dizziness | 3 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Somnolence | 6 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Akathisia | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Akinesia | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Cerebral infarction | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Headache | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Lethargy | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Syncope | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Nausea | 6 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Constipation | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Abdominal distension | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Abdominal pain upper | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Epigastric discomfort | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Flatulence | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Vomiting | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Hallucination | 5 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Insomnia | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Hallucination, auditory | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Impulse-control disorder | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Oedema peripheral | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Gait disturbance | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Medication residue | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Orthostatic hypotension | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Hypotension | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Lymphopenia | 2 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Arrhythmia | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Blood uric acid increased | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Weight decreased | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Muscle spasms | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Musculoskeletal stiffness | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Vertigo | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Decreased appetite | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | Asphyxia | 0 Participants |
Primary
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.
Time frame: From the start of treatment (Baseline) up to Week 25
Population: Safety Population: all participants who received at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 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) | Any AE | 58 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 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 Related to Investigational Product (IP) | 33 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 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) | Any SAE | 2 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 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) | SAE Related to Investigational Product (IP) | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 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 Leading to Death | 0 Participants |
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 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 Leading to Withdrawal | 4 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | 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 Leading to Death | 0 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | 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) | Any AE | 56 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | 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) | SAE Related to Investigational Product (IP) | 1 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | 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 Related to Investigational Product (IP) | 35 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | 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 Leading to Withdrawal | 4 Participants |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | 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) | Any SAE | 4 Participants |
Secondary
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.
Time frame: Baseline and Week 24
Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | -0.1 Scores on a scale | Standard Deviation 2.87 |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | -0.3 Scores on a scale | Standard Deviation 4.64 |
Secondary
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.
Time frame: Week 24
Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | 0.9 Scores on a scale | Standard Deviation 4.03 |
| Placebo in Parent DB Study, Ropinirole PR in OL Study | Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | 1.3 Scores on a scale | Standard Deviation 4.32 |