Restless Legs Syndrome
Conditions
Brief summary
The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).
Detailed description
Study XP055 is a multicenter, open-label, 52-week extension study of XP13512 (Gabapentin Enacarbil \[GEn\]) given once daily to eligible subjects with Restless Legs Syndrome (RLS) who had previously completed 1 of the following studies and met eligibility criteria: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).
Interventions
DRUGXP13512 (GEn)
1200 mg XP13512, orally, once daily for 52 weeks
Sponsors
XenoPort, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have successfully completed one of the following studies: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).
Exclusion criteria
* Subjects who, in the opinion of the Investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC) | Baseline and Week 52 | The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms. |
| Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Weeks 0, 1, 4, 12, 24, 36, and 52 | The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved or improved, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Weeks 0, 1, 4, 12, 24, 36, and 52 | The Participant-rated CGI-I is a self-reported measure completed by the participant, who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse. Responders on the Participant-rated CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved and improved, respectively. |
| Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Weeks 0, 1, and 52 | The Participant-rated CGI-I is a self-reported measure completed by the participant who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study. |
| Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | Week 52 | In the 24-Hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12PM, 12 to 4PM, 4 to 8PM, 6 to 10PM, 8 to 12 Midnight, Midnight to 4AM, 4 to 8AM). |
| Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 | Weeks 24 and 52 | The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms for a 24-hour period, in 30-min increments, beginning at 8AM on the day prior to the visit. |
| Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Weeks 0, 1, 4, 12, 24, and 36 | The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the value at each visit minus the baseline value. Change scores with higher values represent greater improvement in RLS symptoms. |
| Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Baseline and Weeks 24 and 52 | The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Each summary score is expressed as a percentage and ranges from 0 to 100, with higher scores indicating more work missed; a negative change from baseline indicates less work missed. Change = the observed value at the current visit minus the observed value at Week 0. Change is calculated only for participants who had a value at both the current visit and at Week 0. |
| Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | Baseline and Weeks 24 and 52 | The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 24/52 minus the observed value at baseline. Absenteeism is recorded as the number of hours missed from work. W, Week; hr, hour. |
| Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity | Baseline and Weeks 24 and 52 | The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 52 minus the observed value at baseline. Productivity affected while working is estimated on a 0 (no effect) to 10 scale (completely preventing productivity). |
| Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52 | Weeks 24 and 52 | The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL. |
| Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Weeks 0, 1, and 52 | The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study. |
Participant flow
Recruitment details
Participants completing one of four parent studies (110963 \[NCT00298623\], 111460 \[NCT00365352\], 111462 \[NCT01332305\], and 111463 \[NCT01332318\]) were eligible to enroll in Study 111490 (NCT00333359) if eligibility criteria were met.
Participants by arm
| Arm | Count |
|---|---|
| Naïve; 1200 mg GEn Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study. | 197 |
| Non-naïve; 1200 mg GEn Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study. | 376 |
| Total | 573 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 29 | 35 |
| Overall Study | Lost to Follow-up | 15 | 25 |
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Protocol Non-compliance | 2 | 8 |
| Overall Study | Termination or Withdrawal by Sponsor | 1 | 1 |
| Overall Study | Treatment Failure | 3 | 8 |
| Overall Study | Withdrawal by Subject | 19 | 37 |
| Overall Study | Withdrew before Receiving One Dose | 2 | 6 |
Baseline characteristics
| Characteristic | Naïve; 1200 mg GEn | Non-naïve; 1200 mg GEn | Total |
|---|---|---|---|
| Age Continuous | 49.5 Years STANDARD_DEVIATION 12.03 | 50.6 Years STANDARD_DEVIATION 11.82 | 50.2 Years STANDARD_DEVIATION 11.89 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 participants | 5 participants | 6 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants | 5 participants | 7 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Unknown | 0 participants | 3 participants | 3 participants |
| Race/Ethnicity, Customized White or Caucasian | 192 participants | 360 participants | 552 participants |
| Sex: Female, Male Female | 119 Participants | 217 Participants | 336 Participants |
| Sex: Female, Male Male | 78 Participants | 159 Participants | 237 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 114 / 197 | 144 / 376 | 258 / 573 |
| serious Total, serious adverse events | 7 / 197 | 14 / 376 | 21 / 573 |
Outcome results
Primary
Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)
The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms.
Time frame: Baseline and Week 52
Population: Safety Population: all participants who received one dose or any part of one dose of GEn. Week 52 (end of treatment) results included only Week 52 observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naïve; 1200 mg GEn | Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC) | -16.3 points on a scale | Standard Deviation 8.23 |
| Non-naïve; 1200 mg GEn | Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC) | -17.0 points on a scale | Standard Deviation 8.2 |
| All Participants; 1200 mg GEn | Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC) | -16.8 points on a scale | Standard Deviation 8.21 |
Primary
Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC
The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved or improved, respectively.
Time frame: Weeks 0, 1, 4, 12, 24, 36, and 52
Population: Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 1, n=185, 363, 548 | 152 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 24, n=138, 305, 443 | 126 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 12, n=150, 324, 474 | 133 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 0, n=197, 376, 573 | 84 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 52, n=126, 262, 388 | 115 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 36, n=132, 281, 413 | 120 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 4, n=171, 354, 525 | 143 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 12, n=150, 324, 474 | 297 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 0, n=197, 376, 573 | 300 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 1, n=185, 363, 548 | 294 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 4, n=171, 354, 525 | 308 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 24, n=138, 305, 443 | 275 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 36, n=132, 281, 413 | 260 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 52, n=126, 262, 388 | 247 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 24, n=138, 305, 443 | 401 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 1, n=185, 363, 548 | 446 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 52, n=126, 262, 388 | 362 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 36, n=132, 281, 413 | 380 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 12, n=150, 324, 474 | 430 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 4, n=171, 354, 525 | 451 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | Week 0, n=197, 376, 573 | 384 participants |
Secondary
Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC
The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the value at each visit minus the baseline value. Change scores with higher values represent greater improvement in RLS symptoms.
Time frame: Weeks 0, 1, 4, 12, 24, and 36
Population: Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 0, n=197, 376, 573 | -9.4 points on a scale | Standard Deviation 8.08 |
| Naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 1, n=186, 360, 546 | -15.6 points on a scale | Standard Deviation 7.44 |
| Naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 4, n=174, 352, 526 | -15.6 points on a scale | Standard Deviation 7.72 |
| Naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 12, n=150, 322, 472 | -15.8 points on a scale | Standard Deviation 8.76 |
| Naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 24, n=139, 305, 444 | -16.2 points on a scale | Standard Deviation 7.53 |
| Naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 36, n=130, 281, 411 | -16.8 points on a scale | Standard Deviation 7.79 |
| Non-naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 36, n=130, 281, 411 | -16.6 points on a scale | Standard Deviation 8.23 |
| Non-naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 0, n=197, 376, 573 | -14.6 points on a scale | Standard Deviation 8.4 |
| Non-naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 12, n=150, 322, 472 | -16.3 points on a scale | Standard Deviation 7.84 |
| Non-naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 24, n=139, 305, 444 | -16.5 points on a scale | Standard Deviation 7.8 |
| Non-naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 1, n=186, 360, 546 | -13.5 points on a scale | Standard Deviation 8.47 |
| Non-naïve; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 4, n=174, 352, 526 | -15.8 points on a scale | Standard Deviation 7.8 |
| All Participants; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 1, n=186, 360, 546 | -14.2 points on a scale | Standard Deviation 8.19 |
| All Participants; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 4, n=174, 352, 526 | -15.7 points on a scale | Standard Deviation 7.77 |
| All Participants; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 36, n=130, 281, 411 | -16.7 points on a scale | Standard Deviation 8.09 |
| All Participants; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 12, n=150, 322, 472 | -16.1 points on a scale | Standard Deviation 8.14 |
| All Participants; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 0, n=197, 376, 573 | -12.8 points on a scale | Standard Deviation 8.64 |
| All Participants; 1200 mg GEn | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | Week 24, n=139, 305, 444 | -16.4 points on a scale | Standard Deviation 7.71 |
Secondary
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked
The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 24/52 minus the observed value at baseline. Absenteeism is recorded as the number of hours missed from work. W, Week; hr, hour.
Time frame: Baseline and Weeks 24 and 52
Population: Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W24, hr missed due to RLS, n=108, 199, 307 | -0.1 hours | Standard Deviation 1.08 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W24, hr missed for other reason, n=108, 199, 307 | -1.8 hours | Standard Deviation 8.94 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | HW24, hr actually worked, n=108, 199, 307 | 0.8 hours | Standard Deviation 18.09 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W52, hr missed due to RLS, n=82, 175, 257 | 0.1 hours | Standard Deviation 2.39 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W52, hr missed other reason, n=82, 175, 257 | 0.5 hours | Standard Deviation 10.78 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W52, hr actually worked, n=82, 175, 257 | 0.0 hours | Standard Deviation 19.79 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W52, hr actually worked, n=82, 175, 257 | 2.2 hours | Standard Deviation 17.98 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W24, hr missed due to RLS, n=108, 199, 307 | -0.1 hours | Standard Deviation 3.3 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W52, hr missed due to RLS, n=82, 175, 257 | 0.2 hours | Standard Deviation 4.1 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W52, hr missed other reason, n=82, 175, 257 | -1.8 hours | Standard Deviation 11.58 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W24, hr missed for other reason, n=108, 199, 307 | -0.2 hours | Standard Deviation 12.56 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | HW24, hr actually worked, n=108, 199, 307 | 2.5 hours | Standard Deviation 17.6 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W24, hr missed for other reason, n=108, 199, 307 | -0.8 hours | Standard Deviation 11.43 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | HW24, hr actually worked, n=108, 199, 307 | 1.9 hours | Standard Deviation 17.76 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W52, hr actually worked, n=82, 175, 257 | 1.5 hours | Standard Deviation 18.56 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W52, hr missed due to RLS, n=82, 175, 257 | 0.2 hours | Standard Deviation 3.64 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W24, hr missed due to RLS, n=108, 199, 307 | -0.1 hours | Standard Deviation 2.73 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked | W52, hr missed other reason, n=82, 175, 257 | -1.0 hours | Standard Deviation 11.36 |
Secondary
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores
The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Each summary score is expressed as a percentage and ranges from 0 to 100, with higher scores indicating more work missed; a negative change from baseline indicates less work missed. Change = the observed value at the current visit minus the observed value at Week 0. Change is calculated only for participants who had a value at both the current visit and at Week 0.
Time frame: Baseline and Weeks 24 and 52
Population: Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Work Time Missed, n=108, 199, 307 | -0.2 percent change | Standard Deviation 5.24 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Work Time Missed, n=82, 175, 257 | -0.2 percent change | Standard Deviation 7.16 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Daily Activity Impairment, n=117,261,378 | -11.5 percent change | Standard Deviation 20.31 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Overall Work Impairment, n=78, 170, 248 | -8.9 percent change | Standard Deviation 19.25 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Impairment While Working, n=101, 185, 286 | -7.6 percent change | Standard Deviation 19.5 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Overall Work Impairment, n=101, 185, 286 | -7.6 percent change | Standard Deviation 20.39 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Impairment While Working n=78, 170, 248 | -8.7 percent change | Standard Deviation 18.26 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Daily Activity Impairment, n=158,309,467 | -10.3 percent change | Standard Deviation 20.11 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Overall Work Impairment, n=101, 185, 286 | -2.2 percent change | Standard Deviation 11.8 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Impairment While Working, n=101, 185, 286 | -2.3 percent change | Standard Deviation 10.8 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Work Time Missed, n=82, 175, 257 | 1.0 percent change | Standard Deviation 9.86 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Impairment While Working n=78, 170, 248 | -0.9 percent change | Standard Deviation 5.61 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Work Time Missed, n=108, 199, 307 | 0.1 percent change | Standard Deviation 4.88 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Overall Work Impairment, n=78, 170, 248 | -0.8 percent change | Standard Deviation 17.03 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Daily Activity Impairment, n=117,261,378 | -3.9 percent change | Standard Deviation 19.62 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Daily Activity Impairment, n=158,309,467 | -4.3 percent change | Standard Deviation 18.02 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Daily Activity Impairment, n=117,261,378 | -6.3 percent change | Standard Deviation 20.11 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Overall Work Impairment, n=78, 170, 248 | -3.3 percent change | Standard Deviation 18.12 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Work Time Missed, n=108, 199, 307 | 0.0 percent change | Standard Deviation 5 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Impairment While Working, n=101, 185, 286 | -4.2 percent change | Standard Deviation 14.67 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Overall Work Impairment, n=101, 185, 286 | -4.1 percent change | Standard Deviation 15.57 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 24, Daily Activity Impairment, n=158,309,467 | -6.3 percent change | Standard Deviation 18.95 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Impairment While Working n=78, 170, 248 | -3.3 percent change | Standard Deviation 16.85 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | Week 52, Work Time Missed, n=82, 175, 257 | 0.6 percent change | Standard Deviation 9.09 |
Secondary
Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity
The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 52 minus the observed value at baseline. Productivity affected while working is estimated on a 0 (no effect) to 10 scale (completely preventing productivity).
Time frame: Baseline and Weeks 24 and 52
Population: Safety Population: all participants who received one dose or any part of one dose of GEn. Results include only observed cases and do not include early termination values; as such the number of participants analyzed at each week differs from the number of participants in the Baseline characteristics summary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve; 1200 mg GEn | Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity | Week 24, n=101, 185, 286 | -0.8 points on a scale | Standard Deviation 1.95 |
| Naïve; 1200 mg GEn | Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity | Week 52, n=78, 170, 248 | -0.9 points on a scale | Standard Deviation 1.83 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity | Week 24, n=101, 185, 286 | -0.2 points on a scale | Standard Deviation 1.08 |
| Non-naïve; 1200 mg GEn | Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity | Week 52, n=78, 170, 248 | -0.1 points on a scale | Standard Deviation 1.56 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity | Week 24, n=101, 185, 286 | -0.4 points on a scale | Standard Deviation 1.47 |
| All Participants; 1200 mg GEn | Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity | Week 52, n=78, 170, 248 | -0.3 points on a scale | Standard Deviation 1.68 |
Secondary
Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52
The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms for a 24-hour period, in 30-min increments, beginning at 8AM on the day prior to the visit.
Time frame: Weeks 24 and 52
Population: Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Naïve; 1200 mg GEn | Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 | Week 24, n=127, 285, 412 | 15.5 hours |
| Naïve; 1200 mg GEn | Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 | Week 52, n=123, 241, 364 | NA hours |
| Non-naïve; 1200 mg GEn | Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 | Week 24, n=127, 285, 412 | 20 hours |
| Non-naïve; 1200 mg GEn | Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 | Week 52, n=123, 241, 364 | NA hours |
| All Participants; 1200 mg GEn | Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 | Week 24, n=127, 285, 412 | 18 hours |
| All Participants; 1200 mg GEn | Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 | Week 52, n=123, 241, 364 | NA hours |
Secondary
Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC
The Participant-rated CGI-I is a self-reported measure completed by the participant, who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse. Responders on the Participant-rated CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved and improved, respectively.
Time frame: Weeks 0, 1, 4, 12, 24, 36, and 52
Population: Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 0, n=197, 376, 573 | 86 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 36, n=129, 276, 405 | 115 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 4, n=171, 348, 519 | 143 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 52, n=122, 247, 369 | 107 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 1, n=182, 351, 533 | 145 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 24, n=133, 300, 433 | 117 participants |
| Naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 12, n=148, 318, 466 | 131 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 4, n=171, 348, 519 | 299 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 12, n=148, 318, 466 | 283 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 24, n=133, 300, 433 | 275 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 36, n=129, 276, 405 | 252 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 52, n=122, 247, 369 | 227 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 0, n=197, 376, 573 | 304 participants |
| Non-naïve; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 1, n=182, 351, 533 | 261 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 24, n=133, 300, 433 | 392 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 1, n=182, 351, 533 | 406 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 0, n=197, 376, 573 | 390 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 12, n=148, 318, 466 | 414 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 36, n=129, 276, 405 | 367 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 4, n=171, 348, 519 | 442 participants |
| All Participants; 1200 mg GEn | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | Week 52, n=122, 247, 369 | 334 participants |
Secondary
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC
The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study.
Time frame: Weeks 0, 1, and 52
Population: Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Very much worse, n=185, 363, 548 | 0 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Very much improved, n=185, 363, 548 | 82 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Very much worse, n=126, 262, 388 | 0 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, No change, n=126, 262, 388 | 4 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Much improved, n=185, 363, 548 | 70 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Minimally worse, n=126, 262, 388 | 0 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Much worse, n=185, 363, 548 | 1 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Minimally improved, n=185, 363, 548 | 28 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, No change, n=197, 376, 573 | 55 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Minimally worse, n=185, 363, 548 | 0 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, No change, n=185, 363, 548 | 4 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Much improved, n=197, 376, 573 | 46 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Minimally improved, n=126, 262, 388 | 7 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Minimally worse, n=197, 376, 573 | 9 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Very much improved, n=197, 376, 573 | 38 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Much improved, n=126, 262, 388 | 43 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Much worse, n=197, 376, 573 | 2 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Much worse, n=126, 262, 388 | 0 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Very much improved, n=126, 262, 388 | 72 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Very much worse, n=197, 376, 573 | 0 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Minimally improved, n=197, 376, 573 | 47 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Much worse, n=185, 363, 548 | 1 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Very much improved, n=197, 376, 573 | 192 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Much improved, n=197, 376, 573 | 108 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Minimally improved, n=197, 376, 573 | 37 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, No change, n=197, 376, 573 | 36 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Minimally worse, n=197, 376, 573 | 0 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Much worse, n=197, 376, 573 | 2 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Very much worse, n=197, 376, 573 | 1 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Very much improved, n=185, 363, 548 | 155 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Much improved, n=185, 363, 548 | 139 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Minimally improved, n=185, 363, 548 | 40 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, No change, n=185, 363, 548 | 25 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Minimally worse, n=185, 363, 548 | 3 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Very much worse, n=185, 363, 548 | 0 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Very much improved, n=126, 262, 388 | 187 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Much improved, n=126, 262, 388 | 60 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Minimally improved, n=126, 262, 388 | 9 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, No change, n=126, 262, 388 | 4 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Minimally worse, n=126, 262, 388 | 0 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Much worse, n=126, 262, 388 | 1 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Very much worse, n=126, 262, 388 | 1 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Very much worse, n=185, 363, 548 | 0 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Much worse, n=197, 376, 573 | 4 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Minimally worse, n=126, 262, 388 | 0 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Very much improved, n=126, 262, 388 | 259 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Minimally worse, n=197, 376, 573 | 9 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Much improved, n=197, 376, 573 | 154 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Much improved, n=126, 262, 388 | 103 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, No change, n=197, 376, 573 | 91 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Very much worse, n=126, 262, 388 | 1 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Minimally improved, n=126, 262, 388 | 16 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, Much worse, n=126, 262, 388 | 1 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 52, No change, n=126, 262, 388 | 8 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, No change, n=185, 363, 548 | 29 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Minimally improved, n=185, 363, 548 | 68 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Minimally improved, n=197, 376, 573 | 84 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Minimally worse, n=185, 363, 548 | 3 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Much improved, n=185, 363, 548 | 209 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Very much improved, n=185, 363, 548 | 237 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 1, Much worse, n=185, 363, 548 | 2 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Very much worse, n=197, 376, 573 | 1 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | Week 0, Very much improved, n=197, 376, 573 | 230 participants |
Secondary
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC
The Participant-rated CGI-I is a self-reported measure completed by the participant who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study.
Time frame: Weeks 0, 1, and 52
Population: Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Very much improved, n=182, 351, 533 | 91 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Very much improved, n=197, 376, 573 | 39 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Very much improved, n=122, 247, 369 | 80 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Much improved, n=182, 351, 533 | 54 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, No change, n=197, 376, 573 | 50 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Very much worse, n=182, 351, 533 | 1 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Minimally improved, n=182, 351, 533 | 29 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Very much worse, n=122, 247, 369 | 1 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Much worse, n=182, 351, 533 | 2 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, No change, n=182, 351, 533 | 4 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Minimally worse, n=122, 247, 369 | 0 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Minimally worse, n=182, 351, 533 | 1 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Minimally worse, n=197, 376, 573 | 8 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Much worse, n=122, 247, 369 | 0 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, No change, n=122, 247, 369 | 3 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Much worse, n=197, 376, 573 | 5 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Minimally improved, =197, 376, 573 | 47 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Minimally improved, n=122, 247, 369 | 11 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Very much worse, n=197, 376, 573 | 1 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Much improved, n=197, 376, 573 | 47 participants |
| Naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Much improved, n=122, 247, 369 | 27 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Minimally worse, n=122, 247, 369 | 0 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Very much improved, n=197, 376, 573 | 194 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Much improved, n=197, 376, 573 | 110 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Minimally improved, =197, 376, 573 | 35 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, No change, n=197, 376, 573 | 29 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Minimally worse, n=197, 376, 573 | 6 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Much worse, n=197, 376, 573 | 1 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Very much worse, n=197, 376, 573 | 1 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Very much improved, n=182, 351, 533 | 171 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Much improved, n=182, 351, 533 | 90 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Minimally improved, n=182, 351, 533 | 48 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, No change, n=182, 351, 533 | 28 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Minimally worse, n=182, 351, 533 | 6 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Much worse, n=182, 351, 533 | 7 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Very much worse, n=182, 351, 533 | 1 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Very much improved, n=122, 247, 369 | 177 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Much improved, n=122, 247, 369 | 50 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Minimally improved, n=122, 247, 369 | 13 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, No change, n=122, 247, 369 | 5 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Much worse, n=122, 247, 369 | 1 participants |
| Non-naïve; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Very much worse, n=122, 247, 369 | 1 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Very much improved, n=182, 351, 533 | 262 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Much improved, n=197, 376, 573 | 157 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Very much improved, n=122, 247, 369 | 257 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Very much worse, n=197, 376, 573 | 2 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Very much worse, n=122, 247, 369 | 2 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Much improved, n=122, 247, 369 | 77 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Much worse, n=197, 376, 573 | 6 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Much worse, n=122, 247, 369 | 1 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Minimally improved, n=122, 247, 369 | 24 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Minimally worse, n=197, 376, 573 | 14 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Very much improved, n=197, 376, 573 | 233 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, No change, n=122, 247, 369 | 8 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, No change, n=182, 351, 533 | 32 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, No change, n=197, 376, 573 | 79 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Minimally worse, n=182, 351, 533 | 7 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Minimally improved, n=182, 351, 533 | 77 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 0, Minimally improved, =197, 376, 573 | 82 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Much worse, n=182, 351, 533 | 9 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Much improved, n=182, 351, 533 | 144 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 52, Minimally worse, n=122, 247, 369 | 0 participants |
| All Participants; 1200 mg GEn | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | Week 1, Very much worse, n=182, 351, 533 | 2 participants |
Secondary
Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data
In the 24-Hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12PM, 12 to 4PM, 4 to 8PM, 6 to 10PM, 8 to 12 Midnight, Midnight to 4AM, 4 to 8AM).
Time frame: Week 52
Population: Safety Population. Results at Week 52 include only Week 52 observed cases and do not include early termination values; as such, the number of participants with data at each time point differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 12 PM to 4 PM, n=122, 240, 362 | 106 participants |
| Naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 8 PM to 12 AM, n=122, 241, 363 | 75 participants |
| Naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 6 PM to 10 PM, n=122, 241, 363 | 80 participants |
| Naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 8 AM to 12 PM, n=123, 241, 364 | 106 participants |
| Naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 4 AM to 8 AM, n=123, 241, 364 | 104 participants |
| Naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 12 AM to 4 AM, n=123, 241, 364 | 98 participants |
| Naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 4 PM to 8 PM, n=122, 240, 362 | 88 participants |
| Non-naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 6 PM to 10 PM, n=122, 241, 363 | 175 participants |
| Non-naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 8 AM to 12 PM, n=123, 241, 364 | 224 participants |
| Non-naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 12 PM to 4 PM, n=122, 240, 362 | 216 participants |
| Non-naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 4 PM to 8 PM, n=122, 240, 362 | 184 participants |
| Non-naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 8 PM to 12 AM, n=122, 241, 363 | 162 participants |
| Non-naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 12 AM to 4 AM, n=123, 241, 364 | 195 participants |
| Non-naïve; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 4 AM to 8 AM, n=123, 241, 364 | 214 participants |
| All Participants; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 8 PM to 12 AM, n=122, 241, 363 | 237 participants |
| All Participants; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 12 PM to 4 PM, n=122, 240, 362 | 322 participants |
| All Participants; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 4 AM to 8 AM, n=123, 241, 364 | 318 participants |
| All Participants; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 12 AM to 4 AM, n=123, 241, 364 | 293 participants |
| All Participants; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 6 PM to 10 PM, n=122, 241, 363 | 255 participants |
| All Participants; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 4 PM to 8 PM, n=122, 240, 362 | 272 participants |
| All Participants; 1200 mg GEn | Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data | 8 AM to 12 PM, n=123, 241, 364 | 330 participants |
Secondary
Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52
The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.
Time frame: Weeks 24 and 52
Population: Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve; 1200 mg GEn | Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52 | Week 24, n=164, 328, 492 | 89.8 points on a scale | Standard Deviation 12.27 |
| Naïve; 1200 mg GEn | Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52 | Week 52, n=121, 264, 385 | 92.0 points on a scale | Standard Deviation 9.77 |
| Non-naïve; 1200 mg GEn | Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52 | Week 24, n=164, 328, 492 | 91.1 points on a scale | Standard Deviation 12.04 |
| Non-naïve; 1200 mg GEn | Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52 | Week 52, n=121, 264, 385 | 92.0 points on a scale | Standard Deviation 11.66 |
| All Participants; 1200 mg GEn | Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52 | Week 24, n=164, 328, 492 | 90.7 points on a scale | Standard Deviation 12.12 |
| All Participants; 1200 mg GEn | Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52 | Week 52, n=121, 264, 385 | 92.0 points on a scale | Standard Deviation 11.09 |