Trial Outcomes & Findings for Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528 (NCT NCT01536574)

Last Updated: 2018-08-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

295 participants

Primary outcome timeframe

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

Results posted on

2018-08-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	162	133
Overall Study COMPLETED	156	126
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	4	5
Overall Study Withdrawal by Subject	1	2
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n=162 Participants 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.	Placebo in Parent DB Study, Ropinirole PR in OL Study n=133 Participants 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.	Total n=295 Participants Total of all reporting groups
Age, Continuous	64.5 Years STANDARD_DEVIATION 9.10 • n=5 Participants	63.9 Years STANDARD_DEVIATION 9.87 • n=7 Participants	64.2 Years STANDARD_DEVIATION 9.44 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	53 Participants n=7 Participants	104 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	80 Participants n=7 Participants	191 Participants n=5 Participants
Race/Ethnicity, Customized Oriental	162 participants n=5 Participants	133 participants n=7 Participants	295 participants n=5 Participants
Duration of Parkinson's Disease	96.8 months STANDARD_DEVIATION 59.68 • n=5 Participants	105.3 months STANDARD_DEVIATION 49.61 • n=7 Participants	100.7 months STANDARD_DEVIATION 55.44 • n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n=162 Participants 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.	Placebo in Parent DB Study, Ropinirole PR in OL Study n=133 Participants 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.
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	56 Participants
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	35 Participants
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	4 Participants
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	1 Participants
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	0 Participants
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	4 Participants

PRIMARY outcome

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

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n=162 Participants 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.	Placebo in Parent DB Study, Ropinirole PR in OL Study n=133 Participants 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.
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Dyskinesia	6 Participants	10 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Dizziness	5 Participants	3 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Somnolence	0 Participants	6 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Akathisia	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Akinesia	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Cerebral infarction	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Headache	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Lethargy	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Syncope	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Nausea	4 Participants	6 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Constipation	1 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Abdominal distension	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Abdominal pain upper	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Epigastric discomfort	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Flatulence	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Vomiting	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Hallucination	5 Participants	5 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Insomnia	1 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Hallucination, auditory	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Impulse-control disorder	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Oedema peripheral	1 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Gait disturbance	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Medication residue	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Orthostatic hypotension	2 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Hypotension	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Lymphopenia	0 Participants	2 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Arrhythmia	1 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Blood uric acid increased	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Weight decreased	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Muscle spasms	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Musculoskeletal stiffness	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Vertigo	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Decreased appetite	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Asphyxia	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase Pruritus	0 Participants	1 Participants

PRIMARY outcome

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)

Population: Safety Population

Outcome measures

Outcome measures
Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n=162 Participants 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.	Placebo in Parent DB Study, Ropinirole PR in OL Study n=133 Participants 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.
Number of Participants With an Adverse Event During the Follow-up Phase Any AE	2 Participants	3 Participants
Number of Participants With an Adverse Event During the Follow-up Phase AE related to IP	1 Participants	2 Participants
Number of Participants With an Adverse Event During the Follow-up Phase Any SAE	0 Participants	0 Participants

PRIMARY outcome

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)

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n=162 Participants 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.	Placebo in Parent DB Study, Ropinirole PR in OL Study n=133 Participants 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.
Number of Participants With the Indicated Adverse Events During the Follow-up Phase Facial palsy	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events During the Follow-up Phase Parkinsonian rest tremor	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events During the Follow-up Phase Lymphopenia	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events During the Follow-up Phase Hallucination	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events During the Follow-up Phase Choking sensation	1 Participants	0 Participants

PRIMARY outcome

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)

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n=162 Participants 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.	Placebo in Parent DB Study, Ropinirole PR in OL Study n=133 Participants 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.
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase Lymphopenia	1 Participants	0 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase Parkinsonian rest tremor	0 Participants	1 Participants
Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase Hallucination	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n=158 Participants 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.	Placebo in Parent DB Study, Ropinirole PR in OL Study n=129 Participants 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.
Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24	0.9 Scores on a scale Standard Deviation 4.03	1.3 Scores on a scale Standard Deviation 4.32

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n=158 Participants 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.	Placebo in Parent DB Study, Ropinirole PR in OL Study n=129 Participants 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.
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	-0.3 Scores on a scale Standard Deviation 4.64

Adverse Events

Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study

Serious events: 2 serious events

Other events: 58 other events

Deaths: 0 deaths

Placebo in Parent DB Study, Ropinirole PR in OL Study

Serious events: 4 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study n=162 participants at risk 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.	Placebo in Parent DB Study, Ropinirole PR in OL Study n=133 participants at risk 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.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/162 • 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).	0.75% 1/133 • 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).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/162 • 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).	0.75% 1/133 • 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).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/162 • 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).	0.75% 1/133 • 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).
Eye disorders Retinal hemorrhage	0.62% 1/162 • 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).	0.00% 0/133 • 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).
Gastrointestinal disorders Constipation	0.00% 0/162 • 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).	0.75% 1/133 • 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).
Infections and infestations Pneumonia	0.62% 1/162 • 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).	0.00% 0/133 • 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).
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/162 • 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).	0.75% 1/133 • 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).
Nervous system disorders Coma	0.62% 1/162 • 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).	0.00% 0/133 • 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).
Psychiatric disorders Hallucination	0.00% 0/162 • 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).	0.75% 1/133 • 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

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER