Restless Legs Syndrome
Conditions
Brief summary
The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).
Detailed description
This study was a multicenter, blinded, randomized withdrawal study in subjects with primary Restless Legs Syndrome (RLS). Eligible subjects were initially enrolled in a 24-week single blind (SB) treatment period during which they received XP13512. Subjects who completed the initial treatment period and met the responder criteria were then randomized 1:1 to receive either XP13512 or placebo during the 12-week double-blind (DB) treatment period. The primary study objective was to assess the maintenance of efficacy of XP13512 1200 mg taken once daily in the long-term treatment of subjects with primary RLS. The secondary study objectives were to assess maintenance of improvements in sleep outcomes and quality of life, and to assess the safety and tolerability of XP13512 in the treatment of primary RLS subjects.
Interventions
DRUGGEn (XP13512)
1200 mg GEn (XP13512) orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks
DRUGPlacebo
Placebo, orally, once daily for 12 weeks following single blind 24-week phase
Sponsors
XenoPort, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
Exclusion criteria
* A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS; * Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's disease, Multiple Sclerosis, dyskinesias, and dystonias); * Abnormal laboratory results, electrocardiogram (ECG) or physical findings; * Pregnant or lactating women; * Women of childbearing potential who are not practicing an acceptable method of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period | DB Treatment Period; Days 169 to 252 (Weeks 24 to 36) | Relapse was defined as worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week double-blind (DB) treatment period (the period from Randomization on Visit 14 \[Week 24\] through the end of treatment). Worsening of symptoms was defined as an increase in the total International RLS (IRLS) Scale score by at least 6 or more points relative to the participant's score at Randomization, achieving an IRLS score of at least 15, and an assessment of much worse or very much worse on the investigator-rated Clinical Global Impression of Change (CGI-C). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase) | DB Treatment Period; Days 184 to 252 (Weeks 26 to 36) | Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome. |
| Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF) | Randomization (Week 24) and Week 36 (or end of DB treatment) | The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. LOCF: Missing data (MD) values were imputed using the last non-missing observation prior to the visit with MD; randomization visit data could be carried forward. |
| Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The CGI-C scale 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 baseline. For this endpoint, response on the CGI-C was defined as participants with a rating of no change, (score of 4) minimally improved, (score of 3) much improved, (score of 2) or very much improved (score of 1) compared to Randomization (Week 24). |
| Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The CGI scale 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 baseline. |
| Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Week 36 (or end of DB treatment) | The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline. |
| Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF | Week 36 (or end of DB treatment) | The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response on the participant-rated CGI-I was defined as a rating of very much improved (score of 1) or much improved (score of 2) compared to Baseline of the SB phase. |
| Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps \> 5 minutes. For daytime somnolence, a negative value indicates an improvement. |
| Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance. |
| Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep. |
| Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month. |
| Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score | Randomization (Week 24) and Week 36 (or end of DB treatment) | 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 With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | Week 36 (or end of DB treatment) | 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-hr intervals (8 AM to 12 PM, 12 to 4 PM, 4 to 8 PM, 6 to 10 PM, 8 to Midnight, Midnight to 4 AM, 4 to 8 AM) |
| Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase) | Week 36 (or end of DB treatment) | The 24-hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event; thus, no data are presented for the DB GEn 1200 mg arm. |
| Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
| Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
| Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period | DB Treatment Period; Days 169 to 252 (Weeks 24 to 36) | Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome. |
| Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
| Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
| Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF | Days 1 to 168 (Baseline to Week 24 of SB Phase) | The IRLS Rating scale is a measure of disease severity. The scale reflects participant-reported assessment of sensory and motor features and associated sleep problems in RLS. In addition, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. Total score ranges from 0-40 points, with 40 being the most severe. |
| Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The CGI-I scale 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 baseline. |
| Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity 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 baseline. |
| Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps \> 5 minutes. For daytime somnolence, a negative value indicates an improvement. |
| Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. . The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance. |
| Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep. |
| Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month. |
| Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase) | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | 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 With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
| Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
| Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
| Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
| Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
| Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization (Week 24) and Week 36 (or end of DB treatment) | The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement. |
Participant flow
Pre-assignment details
There were 27 participants who completed the Single-blind Treatment Period who either elected not to enroll into the Double-blind Treatment Period or were considered non-responders and were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| SB GEn 1200 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn). | 326 |
| DB Placebo Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet. | 98 |
| DB GEn 1200 mg Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet. | 96 |
| Total | 520 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 12-Week Double-Blind Treatment Period | Adverse Event | 0 | 3 | 0 |
| 12-Week Double-Blind Treatment Period | Lack of Efficacy | 0 | 6 | 4 |
| 12-Week Double-Blind Treatment Period | Lost to Follow-up | 0 | 1 | 2 |
| 12-Week Double-Blind Treatment Period | Per Sponsor, Unknown | 0 | 1 | 0 |
| 12-Week Double-Blind Treatment Period | Protocol Violation | 0 | 1 | 2 |
| 12-Week Double-Blind Treatment Period | Withdrawal by Subject | 0 | 2 | 4 |
| 24-Week Single-Blind Treatment Period | Adverse Event | 42 | 0 | 0 |
| 24-Week Single-Blind Treatment Period | Death | 1 | 0 | 0 |
| 24-Week Single-Blind Treatment Period | Elective Surgery | 1 | 0 | 0 |
| 24-Week Single-Blind Treatment Period | Lack of Efficacy | 13 | 0 | 0 |
| 24-Week Single-Blind Treatment Period | Lost to Follow-up | 12 | 0 | 0 |
| 24-Week Single-Blind Treatment Period | Pregnancy | 1 | 0 | 0 |
| 24-Week Single-Blind Treatment Period | Protocol Violation | 8 | 0 | 0 |
| 24-Week Single-Blind Treatment Period | Withdrawal by Subject | 27 | 0 | 0 |
| 24-Week Single-Blind Treatment Period | Work Shift Changed to Evenings | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | SB GEn 1200 mg | DB Placebo | DB GEn 1200 mg |
|---|---|---|---|---|
| Age Continuous | 51.5 Years STANDARD_DEVIATION 11.87 | 49.8 Years STANDARD_DEVIATION 12.38 | 52.2 Years STANDARD_DEVIATION 12.07 | 50.7 Years STANDARD_DEVIATION 11.68 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 23 participants | 16 participants | 5 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 5 participants | 3 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other, Syrian | 1 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White or Caucasian | 490 participants | 305 participants | 92 participants | 93 participants |
| Sex: Female, Male Female | 303 Participants | 188 Participants | 53 Participants | 62 Participants |
| Sex: Female, Male Male | 217 Participants | 138 Participants | 45 Participants | 34 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 | 179 / 326 | 15 / 98 | 13 / 96 |
| serious Total, serious adverse events | 3 / 326 | 2 / 98 | 1 / 96 |
Outcome results
Primary
Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period
Relapse was defined as worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week double-blind (DB) treatment period (the period from Randomization on Visit 14 \[Week 24\] through the end of treatment). Worsening of symptoms was defined as an increase in the total International RLS (IRLS) Scale score by at least 6 or more points relative to the participant's score at Randomization, achieving an IRLS score of at least 15, and an assessment of much worse or very much worse on the investigator-rated Clinical Global Impression of Change (CGI-C).
Time frame: DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Placebo | Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period | 22.7 percentage of participants |
| DB GEn 1200 mg | Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period | 9.4 percentage of participants |
p-value: 0.015895% CI: [0.2, 0.8]Regression, Logistic
Secondary
Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF
The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Placebo | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | Randomization | 73.3 points on a scale | Standard Deviation 19.3 |
| DB Placebo | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | Week 36 | 61.6 points on a scale | Standard Deviation 28.57 |
| DB Placebo | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | Change from Randomization to Week 36 | -11.6 points on a scale | Standard Deviation 24.01 |
| DB GEn 1200 mg | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | Randomization | 74.6 points on a scale | Standard Deviation 21.37 |
| DB GEn 1200 mg | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | Week 36 | 70.3 points on a scale | Standard Deviation 25.11 |
| DB GEn 1200 mg | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | Change from Randomization to Week 36 | -4.3 points on a scale | Standard Deviation 22.28 |
Secondary
Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF
The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Placebo | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF | Randomization | 7.0 hours | Standard Deviation 0.95 |
| DB Placebo | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF | Week 36 | 6.8 hours | Standard Deviation 1.18 |
| DB Placebo | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF | Change from Randomization to Week 36 | -0.2 hours | Standard Deviation 0.9 |
| DB GEn 1200 mg | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF | Randomization | 7.0 hours | Standard Deviation 0.92 |
| DB GEn 1200 mg | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF | Week 36 | 6.9 hours | Standard Deviation 1.1 |
| DB GEn 1200 mg | Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF | Change from Randomization to Week 36 | -0.1 hours | Standard Deviation 0.92 |
Secondary
Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score
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: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Placebo | Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score | Change from Randomization to Week 36 | -4.2 points on a scale | Standard Deviation 11.53 |
| DB Placebo | Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score | Randomization | 94.1 points on a scale | Standard Deviation 6.74 |
| DB Placebo | Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score | Week 36 | 89.9 points on a scale | Standard Deviation 12.62 |
| DB GEn 1200 mg | Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score | Week 36 | 92.1 points on a scale | Standard Deviation 9.16 |
| DB GEn 1200 mg | Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score | Randomization | 94.3 points on a scale | Standard Deviation 6.46 |
| DB GEn 1200 mg | Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score | Change from Randomization to Week 36 | -2.2 points on a scale | Standard Deviation 7.86 |
Secondary
Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF
The IRLS Rating scale is a measure of disease severity. The scale reflects participant-reported assessment of sensory and motor features and associated sleep problems in RLS. In addition, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. Total score ranges from 0-40 points, with 40 being the most severe.
Time frame: Days 1 to 168 (Baseline to Week 24 of SB Phase)
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Placebo | Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF | Baseline | 24.7 points on a scale | Standard Deviation 5.48 |
| DB Placebo | Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF | Week 24 | 9.2 points on a scale | Standard Deviation 8.35 |
| DB Placebo | Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF | Change from Baseline to Week 24 | -15.5 points on a scale | Standard Deviation 9.16 |
Secondary
Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF
The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 12 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Placebo | Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF | 1.0 hours | Standard Deviation 1.45 |
Secondary
Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase)
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: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 13 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Placebo | Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase) | 25.7 points on a scale | Standard Deviation 18.43 |
Secondary
Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF
The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps \> 5 minutes. For daytime somnolence, a negative value indicates an improvement.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Placebo | Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | -21.8 points on a scale | Standard Deviation 22.13 |
Secondary
Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF
The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Placebo | Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF | 35.7 points on a scale | Standard Deviation 30.3 |
Secondary
Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF
The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. . The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Placebo | Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | -35.3 points on a scale | Standard Deviation 24.92 |
Secondary
Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF
The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps \> 5 minutes. For daytime somnolence, a negative value indicates an improvement.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Placebo | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | Randomization | 11.8 points on a scale | Standard Deviation 12.2 |
| DB Placebo | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | Week 36 | 15.5 points on a scale | Standard Deviation 16.21 |
| DB Placebo | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | Change from Randomization to Week 36 | 3.8 points on a scale | Standard Deviation 13.33 |
| DB GEn 1200 mg | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | Randomization | 11.0 points on a scale | Standard Deviation 14.66 |
| DB GEn 1200 mg | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | Week 36 | 12.6 points on a scale | Standard Deviation 15.68 |
| DB GEn 1200 mg | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF | Change from Randomization to Week 36 | 1.5 points on a scale | Standard Deviation 11.67 |
Secondary
Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF
The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Placebo | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | Randomization | 16.7 points on a scale | Standard Deviation 14.37 |
| DB Placebo | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | Week 36 | 26.9 points on a scale | Standard Deviation 21.24 |
| DB Placebo | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | Change from Randomization to Week 36 | 10.2 points on a scale | Standard Deviation 19.02 |
| DB GEn 1200 mg | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | Randomization | 18.8 points on a scale | Standard Deviation 17.21 |
| DB GEn 1200 mg | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | Week 36 | 21.0 points on a scale | Standard Deviation 19.58 |
| DB GEn 1200 mg | Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF | Change from Randomization to Week 36 | 2.3 points on a scale | Standard Deviation 18.32 |
Secondary
Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF)
The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. LOCF: Missing data (MD) values were imputed using the last non-missing observation prior to the visit with MD; randomization visit data could be carried forward.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Placebo | Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF) | Randomization | 5.3 points on a scale | Standard Deviation 4.63 |
| DB Placebo | Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF) | Week 36 | 9.2 points on a scale | Standard Deviation 6.76 |
| DB Placebo | Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF) | Mean change from Randomization to Week 36 | 3.9 points on a scale | Standard Deviation 6.49 |
| DB GEn 1200 mg | Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF) | Randomization | 5.1 points on a scale | Standard Deviation 4.2 |
| DB GEn 1200 mg | Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF) | Week 36 | 7.0 points on a scale | Standard Deviation 7.47 |
| DB GEn 1200 mg | Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF) | Mean change from Randomization to Week 36 | 1.9 points on a scale | Standard Deviation 7.01 |
Secondary
Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase)
The 24-hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event; thus, no data are presented for the DB GEn 1200 mg arm.
Time frame: Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DB Placebo | Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase) | 14.5 hours |
Secondary
Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF
The CGI scale 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 baseline.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | No change (score of 4) | 44 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Minimally worse (score of 5) | 14 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Much improved (score of 2) | 5 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Much worse (score of 6) | 11 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Very much improved (score of 1) | 4 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Very much worse (score of 7) | 7 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Minimally improved (score of 3) | 12 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Very much worse (score of 7) | 2 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Very much improved (score of 1) | 10 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Much improved (score of 2) | 3 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | No change (score of 4) | 44 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Minimally worse (score of 5) | 13 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Much worse (score of 6) | 9 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF | Minimally improved (score of 3) | 15 participants |
Secondary
Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF
The CGI-I scale 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 baseline.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Minimally Improved (score of 3) | 28 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Very Much Improved (score of 1) | 170 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Much Improved (score of 2) | 78 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | No change (score of 4) | 25 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Minimally worse (score of 5) | 4 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Much Worse (score of 6) | 4 participants |
| DB Placebo | Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Very Much Worse (score of 7) | 2 participants |
Secondary
Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF
The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity 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 baseline.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 3 had missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Very Much Improved (score of 1) | 163 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Much Improved (score of 2) | 82 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Minimally Improved (score of 3) | 38 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | No Change (score of 4) | 16 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Minimally Worse (score of 5) | 7 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Much Worse (score of 6) | 0 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF | Very Much Worse (score of 7) | 2 participants |
Secondary
Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF
The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline.
Time frame: Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | No change (score of 4) | 8 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Very much improved (score of 1) | 47 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Minimally worse (score of 5) | 3 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Minimally improved (score of 3) | 7 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Much worse (score of 6) | 1 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Very much worse (score of 7) | 1 participants |
| DB Placebo | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Much improved (score of 2) | 30 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Very much worse (score of 7) | 1 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Very much improved (score of 1) | 60 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Much improved (score of 2) | 24 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Minimally improved (score of 3) | 4 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | No change (score of 4) | 6 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Minimally worse (score of 5) | 0 participants |
| DB GEn 1200 mg | Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF | Much worse (score of 6) | 1 participants |
Secondary
Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase)
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-hr intervals (8 AM to 12 PM, 12 to 4 PM, 4 to 8 PM, 6 to 10 PM, 8 to Midnight, Midnight to 4 AM, 4 to 8 AM)
Time frame: Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population Participants who were missing severity scores for more than two 30-min windows during a 4-hour period had their maximum severity rating for the 4-hour period set to missing. At Randomization (Week 24), there was one participant in each arm with missing 24-hour RLS Record data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 8 AM to 12 PM, Randomization, n=96, 95 | 83 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 8 AM to 12 PM, Week 36, n=87, 89 | 72 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 12 PM to 4 PM, Randomization, n=96, 95 | 85 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 12 PM to 4 PM, Week 36, n=87, 89 | 71 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 4 PM to 8 PM, Randomization, n=96, 95 | 73 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 4 PM to 8 PM, Week 36, n=87, 89 | 68 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 6 PM to 10 PM, Randomization, n=96, 95 | 66 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 6 PM to 10 PM, Week 36, n=87, 89 | 53 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 8 PM to 12 AM, Randomization, n=96, 95 | 62 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 8 PM to 12 AM, Week 36, n=87, 89 | 41 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 12 AM to 4 AM, Randomization, n=96, 95 | 82 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 12 AM to 4 AM, Week 36, n=87, 89 | 66 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 4 AM to 8 AM, Randomization, n=96, 95 | 83 participants |
| DB Placebo | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 4 AM to 8 AM, Week 36, n=87, 89 | 67 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 12 AM to 4 AM, Randomization, n=96, 95 | 79 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 8 AM to 12 PM, Randomization, n=96, 95 | 88 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 6 PM to 10 PM, Week 36, n=87, 89 | 62 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 8 AM to 12 PM, Week 36, n=87, 89 | 83 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 4 AM to 8 AM, Randomization, n=96, 95 | 83 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 12 PM to 4 PM, Randomization, n=96, 95 | 85 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 8 PM to 12 AM, Randomization, n=96, 95 | 59 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 12 PM to 4 PM, Week 36, n=87, 89 | 78 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 12 AM to 4 AM, Week 36, n=87, 89 | 77 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 4 PM to 8 PM, Randomization, n=96, 95 | 68 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 8 PM to 12 AM, Week 36, n=87, 89 | 61 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 4 PM to 8 PM, Week 36, n=87, 89 | 72 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 4 AM to 8 AM, Week 36, n=87, 89 | 80 participants |
| DB GEn 1200 mg | Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase) | 6 PM to 10 PM, Randomization, n=96, 95 | 61 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Excellent | 53 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Good | 42 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Moderate | 2 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Poor | 0 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Excellent | 44 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Good | 43 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Moderate | 9 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Poor | 1 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Poor | 3 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Excellent | 63 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Excellent | 53 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Good | 28 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Moderate | 8 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Moderate | 4 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Good | 32 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Poor | 1 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Excellent | 38 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Reasonable | 56 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Poor | 3 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Excellent | 29 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Reasonable | 51 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Poor | 17 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Reasonable | 46 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Excellent | 43 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Excellent | 38 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Reasonable | 46 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, Poor | 12 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, Poor | 7 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, Excellent | 20 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, Good | 124 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, Moderate | 141 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, Poor | 26 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, Excellent | 145 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, Good | 127 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, Moderate | 29 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, Poor | 10 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 0 times | 73 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 1-2 times | 22 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 3-4 times | 2 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 5 or more times | 0 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 0 times | 53 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 1-2 times | 35 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 3-4 times | 7 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 5 or more times | 2 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 5 or more times | 1 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 0 times | 72 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 0 times | 68 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 1-2 times | 22 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 3-4 times | 5 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 3-4 times | 1 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 1-2 times | 22 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 5 or more times | 1 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 0 times | 26 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 1-2 times | 131 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 3-4 times | 113 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 5 or more times | 41 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 0 times | 188 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 1-2 times | 98 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 3-4 times | 18 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 5 or more times | 7 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 0 hours (hr) | 26 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, less than 1 hr | 78 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 1 hr to less than 2 hr | 107 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 2 hr to less than 3 hr | 60 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 3 or more hr | 40 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 0 hr | 188 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, less than 1 hr | 63 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 1 hr to less than 2 hr | 37 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 2 hr to less than 3 hr | 17 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 3 or more hr | 6 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 0 hours (hr) | 73 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, less than 1 hr | 14 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 1 hr to less than 2 hr | 7 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 2 hr to less than 3 hr | 2 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 3 or more hr | 1 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 0 hr | 53 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, less than 1 hr | 24 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 1 hr to less than 2 hr | 15 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 2 hr to less than 3 hr | 2 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 3 or more hr | 3 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 1 hr to less than 2 hr | 8 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 0 hours (hr) | 72 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 0 hr | 68 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, less than 1 hr | 16 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 3 or more hr | 0 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 1 hr to less than 2 hr | 5 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, less than 1 hr | 17 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 2 hr to less than 3 hr | 3 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 2 hr to less than 3 hr | 3 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 3 or more hr | 0 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 0 nights | 1 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 1-2 nights | 1 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline 3-4 nights | 36 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline 5-6 nights | 122 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, 7 nights | 151 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 0 nights | 106 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 1-2 nights | 98 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 3-4 nights | 37 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 5-6 nights | 24 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, 7 nights | 46 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 5-6 nights | 3 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 0 nights | 47 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 1-2 nights | 35 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 3-4 nights | 8 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 7 nights | 4 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 0 nights | 30 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 1-2 nights | 30 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 3-4 nights | 17 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 5-6 nights | 6 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 7 nights | 14 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 3-4 nights | 12 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 5-6 nights | 5 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 0 nights | 41 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 0 nights | 38 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 7 nights | 7 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 1-2 nights | 36 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 1-2 nights | 30 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 3-4 nights | 11 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Week 36, 5-6 nights | 6 participants |
| DB GEn 1200 mg | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF | Randomization, 7 nights | 6 participants |
Secondary
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.
Time frame: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase
Population: Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, Excellent | 3 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, Reasonable | 97 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Baseline, Poor | 211 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, Excellent | 102 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, Reasonable | 164 participants |
| DB Placebo | Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF | Week 24, Poor | 45 participants |
Secondary
Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF
The CGI-C scale 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 baseline. For this endpoint, response on the CGI-C was defined as participants with a rating of no change, (score of 4) minimally improved, (score of 3) much improved, (score of 2) or very much improved (score of 1) compared to Randomization (Week 24).
Time frame: Randomization (Week 24) and Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Placebo | Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF | 67 percentage of participants |
| DB GEn 1200 mg | Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF | 75 percentage of participants |
Secondary
Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF
The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response on the participant-rated CGI-I was defined as a rating of very much improved (score of 1) or much improved (score of 2) compared to Baseline of the SB phase.
Time frame: Week 36 (or end of DB treatment)
Population: Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Placebo | Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF | 79.4 percentage of participants |
| DB GEn 1200 mg | Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF | 87.5 percentage of participants |
Secondary
Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period
Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.
Time frame: DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)
Population: DB ITT Population
Secondary
Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase)
Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.
Time frame: DB Treatment Period; Days 184 to 252 (Weeks 26 to 36)
Population: DB ITT Population