gamma-aminobutyric acid and Restless Legs Syndrome

gamma-aminobutyric acid has been researched along with Restless Legs Syndrome in 101 studies

gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.
gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.

Restless Legs Syndrome: A disorder characterized by aching or burning sensations in the lower and rarely the upper extremities that occur prior to sleep or may awaken the patient from sleep.

Research

Studies (101)

Authors

Clinical Trials (13)

Trial Overview

Trial Outcomes

Change From Baseline in Limb Pain-VAS at Week 12

100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. Change = observation mean minus baseline mean. (NCT00806026)
Timeframe: Baseline, Week 12

Change From Baseline in RLS-NDI at Week 12

The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact. (NCT00806026)
Timeframe: Baseline, Week 12

Change From Baseline in SSQ: Subjective WASO at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep. (NCT00806026)
Timeframe: Baseline, Week 12

Change From Baseline in the RLS Symptom Severity at Week 12

IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life. (NCT00806026)
Timeframe: Baseline, Week 12

Clinical Global Impressions-Severity (CGI-S) at Week 12

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal-not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected. (NCT00806026)
Timeframe: Week 12

Limb Pain-Visual Analog Scale (Limb Pain-VAS)

100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. (NCT00806026)
Timeframe: Baseline

Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12

MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/ headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Optimal sleep subscale scores range: 0-1; Optimal sleep = 1 if 'Average hours sleep' = 7 or 8, is 0 if 'Average hours sleep' is non-missing and less than 7, and is missing if 'Average hours sleep' is missing. Higher scores reflect better sleep outcomes. (NCT00806026)
Timeframe: Week 12

Percentage of Participants Responding to Treatment at Week 12

"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of very much improved or much improved." (NCT00806026)
Timeframe: Week 12

Percentage of Participants With Augmentation

Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation. (NCT00806026)
Timeframe: Baseline up to Week 52

Restless Legs Syndrome (RLS) Symptom Severity

International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life. (NCT00806026)
Timeframe: Baseline

Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12

RLS QoL: Participant rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. (NCT00806026)
Timeframe: Week 12

RLS-Next Day Impact (RLS-NDI)

The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact. (NCT00806026)
Timeframe: Baseline

Severity of Augmentation Symptoms at Week 12

ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation. (NCT00806026)
Timeframe: Week 12

Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Hours of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep. (NCT00806026)
Timeframe: Week 12

Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Latency subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep. (NCT00806026)
Timeframe: Week 12

Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Number of awakenings subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Number of awakenings subscale score ranges from 0-30. Lower value indicates better sleep. (NCT00806026)
Timeframe: Week 12

Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Quality of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep. (NCT00806026)
Timeframe: Week 12

Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep. (NCT00806026)
Timeframe: Baseline

Medical Outcomes Study-Short Form 36 (SF-36) at Week 12

"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from 0=much worse now to 4=much better now. Higher subscale and summary score reflect better health status." (NCT00806026)
Timeframe: Week 12

Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12

MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Sleep adequacy data was reported at week 12 and not for first 12 weeks (average). Subscale scores range: 0-100; exception quantity of sleep (range 0-24 hours). With exception of sleep quantity and sleep adequacy, higher scores reflect poorer sleep outcomes. (NCT00806026)
Timeframe: Week 12

Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12

WPAI: 6 question participant rated questionnaire to determine degree to which SHP affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 10 (completely affected/impaired). WPAI outcomes expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. (NCT00806026)
Timeframe: Week 12

Arousal Index (NASOI)

Arousal index, as determined by PSG, was NASO per hours of sleep from the onset of persistent sleep to light on. Arithmetic mean of NASOI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

International Restless Legs Syndrome Study Group Rating Scale (IRLS)

IRLS: psychometrically; clinically valid; clinician-administered instrument assesses severity of RLS. RLS symptom severity and impact on daily living comprise of 10 items giving 2 subscale scores and 1 global score. Subscale scores: symptom severity(6 items) and impact on daily living(3 items), item 3 loaded equally on both subscales. Global score calculated from 10 items. Score of all items range from 0-4, total score range:0-40. Lower scores: lower severity and better quality of life. Arithmetic mean of IRLS of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Latency to Persistent Sleep (LPS)

"LPS, as determined by PSG, was number of epochs from the beginning of the recording (lights-out) to the start of the first 20 consecutive non-wake epochs (10 minutes of persistent sleep) divided by 2. Arithmetic mean of LPS of each participant for all periods was taken prior to employing linear mixed model." (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Latency to Stage R Sleep (LREM)

LREM, as determined by PSG, was number of non-wake epochs from the beginning of the recording to the first occurrence of Stage R sleep divided by 2. Arithmetic mean of LREM of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Number of Arousals (NASO)

NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)

NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM [Stage N2] 30-second (30-sec) epoch, Stage 3 Non-REM [Stage N3] 30-sec epoch, or stage rapid eye movement [stage R] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)

NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale

CGI-I: 7-point clinician rated scale to assess improvement in disease condition as compared to the start of the study medication (baseline), ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved). Higher score = more affected. (NCT00991276)
Timeframe: Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Periodic Limb Movement Arousal Index (PLMAI)

PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time [TST]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Periodic Limb Movement in Sleep Index (PLMSI)

PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Periodic Limb Movement Index (PLMI)

PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)

RLS-QoL: psychometrically and clinically valid and reliable participant-rated instrument, assesses impact of RLS on participant quality of life. Specifically, it assessed effects of RLS on health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, travelling, sexual activity, and work) giving a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period: 1 week prior to assessment. Arithmetic mean of RLS-QoL score of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Restless Legs Syndrome-Next Day Impact (RLS-NDI)

RLS-NDI:participant-rated instrument to assess daytime performance and participant's previous night's sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 3 and Week 5 of Each Intervention Period or ET

Sleep Efficiency (SE)

SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of SE of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Subjective Sleep Questionnaire (SSQ): Latency Subscale

SSQ: participant-rated instrument assesses sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. Latency (time to fall asleep [in minutes]): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 - 840 minutes, lower value: better sleep. Arithmetic mean of subscale score of each participant for all periods was taken prior to employing linear mixed model. Hours of sleep subscale results reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of each intervention period or ET

Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale

SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This (1 item) subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 awakenings to 30 awakenings. Lower value indicates better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of Each Intervention Period or ET

Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale

SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before, Range: 0 to 100, higher score: better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of each intervention period or ET

Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale

SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale (in minutes): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0-1440 minutes. Lower value: better sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of each intervention period or ET

Subjective Total Sleep Time (sTST)

sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 3 and Week 5 of Each Intervention Period or ET

Total Sleep Time (TST)

TST, as determined by PSG, was the number of non-wake (30-sec) epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of TST of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Wake After Sleep Onset (WASO)

WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep [WTDS] epochs + Wake Time After Sleep [WTAS] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)

Wake Time After Sleep (WTAS)

WTAS, as determined by PSG, was the number of wake (30-sec) epochs after the final awakening until the end of the 8-hour recording. WTAS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTAS of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Wake Time During Sleep (WTDS)

WTDS, as determined by PSG, was the number of wake (30-sec) epochs after the onset of persistent sleep and prior to the final awakening or at the end of 8-hour recording. WTDS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTDS of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Hourly and Quarterly Assessment of Number of Arousals (NASO)

NASO, as determined by PSG was the number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NASO for each participant at each period was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)

NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 30-sec epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)

NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)

PLM, as determined by PSG was number of periodic limb movements based on time in bed (TIB). Calculated at each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of PLM of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Hourly and Quarterly Assessment of Sleep Efficiency (SE)

SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean for SE of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)

WASO, as determined by PSG was time spent awake from sleep onset to final awakening. WASO = (sum of WTDS 30-sec epochs and WTAS 30-sec epochs)/2, measured on 2 consecutive days at end of each intervention period by each individual hour (8 hours total) and each individual quarter of night (eight hours in 2 hour increments). Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Medical Outcomes Study - Sleep Scale (MOS-SS)

MOS-SS:Participant rated instrument, assesses sleep quantity, quality;with 12 items(7 subscale scores:sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep;2 composite index scores:sleep problems Index I, II). Subscale scores total range:0-100(except sleep quantity[range 0-24 hours], optimal sleep[range 0-1: 0= <7 or >8 hours;1=7/8 hours]). Higher scores=poorer sleep outcomes(except sleep quantity, adequacy). Arithmetic mean of MOS-SS scores of each participant for all periods was taken before linear mixed model analysis. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Minutes of Stage N1, N2, N3 and R Sleep

Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Narcotic Utilization

"total narcotic utilization measured with Morphine Milligram Equivalent (MME)~The conversion scale being used will be the Center for Disease Control and Prevention Morphine Equivalent Score.~Lower scores represent less opioid use and a better outcome. Higher scores represent more opioid use and a worse outcome." (NCT03330119)
Timeframe: From time of consent until hospital discharge (3 days)

Mean AUCss

The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12. (NCT01332305)
Timeframe: Weeks 4 and 12

Mean Css, Max and Css, Min

"Css, max is defined as the maximum or peak concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation." (NCT01332305)
Timeframe: Weeks 4 and 12

Mean Tmax and T1/2

"Tmax is defined as the time to the maximum or peak concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body." (NCT01332305)
Timeframe: Weeks 4 and 12

"Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF"

"The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being very much improved, a score of 2 being much improved, a score of 3 being minimally improved, a score of 4 being no change, a score of 5 being minimally improved,a score of 6 being much worse, and a score of 7 being very much worse. Participants with a response of much improved or very much improved were classified as responders." (NCT00365352)
Timeframe: Week 12

Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)

The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline and Week 12

Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep adequacy domain ranged from 1 to 100, with a high score indicating greater adequacy. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Basline and Week 12

Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep quantity domain were measured in time (number of hours of sleep each night). The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Baseline and Week 12

Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF

The Daily RLS pain score was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined study visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value. (NCT00365352)
Timeframe: Baseline and End of Treatment (Week 12)

Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF

The Average Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value. (NCT00365352)
Timeframe: Baseline and Week 12

Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the daytime somnolence domain ranged from 1 to 100, with a high score indicating greater daytime somnolence. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Baseline and Week 12

Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF

The Restless Legs Syndrome Quality of Life (RLS-QoL) questionnaire is a disease-specific, participant-rated questionnaire that assesses the impact of RLS on daily life, emotional well-being, social life, and work life of the participants. The RLS-QoL Questionnaire is presented on a 0 (lowest possible score) to 100 (highest possible score) scale. It was completed at Day 1 and at the end of Weeks 4, 8, and 12 (or Early Termination). (NCT00365352)
Timeframe: Baseline and Week 12

Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF

"The Profile of Mood States (POMS) Brief Form contains 30 adjectives; each participant is asked to rate the degree to which each adjective describes themselves based on how they felt during the past week including the date on which the adjective was rated. The possible ratings range from 0 (Not all all) to 4 (Extremely). The Total Mood Disturbance Score (range of 0 to 120) is obtained by summing the values of six domains. Higher scores indicate a more negative mood disturbance. The POMS was completed at Baseline (Day 1), and at the end of Weeks 4, 8, and 12 (or Early Termination)." (NCT00365352)
Timeframe: Baseline to End of Treatment (Week 12)

Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep disturbance domain ranged from 1 to 100, with a high score indicating greater impairment of sleep. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Baseline and Week 12

Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline (Day 1) and End of Treatment (Week 12)

Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF

Average daily total sleep time was derived from the Pittsburgh Sleep Diary (PghSD; an instrument with separate components to be completed [self-reported] at bedtime and waketime) as the mean of non-missing total sleep time over the 7 days before each visit, where total sleep time = [(wake up time - lights out time) - time to fall asleep - time awake during the night] in hours. The change was calculated as the end of treatment (Week 12) value minus the Baseline value. (NCT00365352)
Timeframe: Baseline to End of Treatment (Week 12)

Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF

Average daily wake time after sleep onset was derived from the Pittsburgh Sleep Diary (PghSD) as the mean of non-missing total hours awake during the night after falling asleep over the 7 days before each visit. The change was calculated as the end of treatment (Week 12) value minus the Baseline value. (NCT00365352)
Timeframe: Baseline to End of Treatment (Week 12)

Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline and the End of Week 1

Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: Week 12

Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF

"The IRLS Rating scale is a measure of RLS disease severity. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved." (NCT00365352)
Timeframe: End of Week 1

Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF

The Mood Assessment is a non-disease-specific question surveying global change in a participant's overall mood. Participants were asked to rate their overall change in mood since the start of the study by choosing a score in a range from 1 (Very Much Improved) to 7 (Very Much Worse). The assessment was completed at Day 1 and the ends of Weeks 4, 8, and 12 or (Early Termination). (NCT00365352)
Timeframe: Week 12

Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF

"The Post-Sleep Questionnaire (PSQ) was designed to evaluate overall sleep quality, ability to function, and RLS symptoms' interference with sleep over the past week. Participants were asked to rate overall sleep quality (as either Excellent, Reasonable, or Poor), ability to function, number of nights with RLS symptoms, number of nights awakened by RLS symptoms, and the number of hours spent awake due to RLS symptoms over the past week." (NCT00365352)
Timeframe: End of Treatment (Week 12)

Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: End of Week 1

The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I

The Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved. The median time to onset is estimated using the product-limit estimation method. (NCT00365352)
Timeframe: Baseline (Day 1) to End of Treatment (Week 12)

Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)

The time to onset of the first RLS symptoms from the 24-hour RLS Record is defined as the length of time from the start of the 24-hour assessment period (8:00 AM) to the time when 50% of participants experienced their first symptom. (NCT00365352)
Timeframe: Week 12

Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline (Day 1) and Week 12

Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline (Day 1) and Week 12

Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: Basline and Week 12

Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: Week 1 and Week 12

Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF

"The Mean Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits A Responder is a participant with a score of much improved or very much improved on the investigator rated CGI I Scale at the end of treatment (Week 12 using LOCF)." (NCT00365352)
Timeframe: Week 12

Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)

RLS severity ratings were summarized in 6 non-overlapping 4-hour periods beginning at 8 AM. A 4-hour period from 6 PM to 10 PM was also prospectively included to reflect the time frame when the most participants would experience their first symptoms of the day. (NCT00365352)
Timeframe: Week 12

Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6

IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 6

Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6

RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 6

Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6

Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6

Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6

Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night. (NCT00676403)
Timeframe: Week 1, Week 2, Week 4, Week 6

Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6

Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6

Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline,, Week 1, Week 2, Week 4, Week 6

Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6

Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline,, Week 1, Week 2, Week 4, Week 6

Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores

"Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from much worse now to much better now. Recall period: month prior to the assessment." (NCT00676403)
Timeframe: Baseline, Week 6

Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 6

Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)

Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved. (NCT00676403)
Timeframe: Week 6

Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)

CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)

Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep [in minutes]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

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. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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. (NCT00311363)
Timeframe: Week 36 (or end of DB treatment)

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)." (NCT00311363)
Timeframe: DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)

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)." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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." (NCT00311363)
Timeframe: Week 36 (or end of DB treatment)

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. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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. (NCT00311363)
Timeframe: Days 1 to 168 (Baseline to Week 24 of 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

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. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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." (NCT00311363)
Timeframe: Week 36 (or end of DB treatment)

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) (NCT00311363)
Timeframe: Week 36 (or end of DB treatment)

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." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

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." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

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." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Reviews

35 reviews available for gamma-aminobutyric acid and Restless Legs Syndrome

Trials

32 trials available for gamma-aminobutyric acid and Restless Legs Syndrome

Other Studies

34 other studies available for gamma-aminobutyric acid and Restless Legs Syndrome