XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.

The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms.

The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being "very much improved" and a score of 7 being "very much worse" compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to "very much improved" or "improved," respectively.

The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the value at each visit minus the baseline value. Change scores with higher values represent greater improvement in RLS symptoms.

The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being "very much improved," 2 being "much improved," 3 being "minimally improved," 4 being "no change," 5 being "minimally worse," 6 being "much worse," and 7 being "very much worse" compared to the start of the study.

The Participant-rated CGI-I is a self-reported measure completed by the participant, who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being "very much improved" and a score of 7 being "very much worse". Responders on the Participant-rated CGI-I are defined as those with a score of 1 or 2, corresponding to "very much improved" and "improved," respectively.

The Participant-rated CGI-I is a self-reported measure completed by the participant who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being "very much improved," 2 being "much improved," 3 being "minimally improved," 4 being "no change," 5 being "minimally worse," 6 being "much worse," and 7 being "very much worse" compared to the start of the study.

In the 24-Hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12PM, 12 to 4PM, 4 to 8PM, 6 to 10PM, 8 to 12 Midnight, Midnight to 4AM, 4 to 8AM).

The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms for a 24-hour period, in 30-min increments, beginning at 8AM on the day prior to the visit.

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.

The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Each summary score is expressed as a percentage and ranges from 0 to 100, with higher scores indicating more work missed; a negative change from baseline indicates less work missed. Change = the observed value at the current visit minus the observed value at Week 0. Change is calculated only for participants who had a value at both the current visit and at Week 0.

The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 24/52 minus the observed value at baseline. Absenteeism is recorded as the number of hours missed from work. W, Week; hr, hour.

The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 52 minus the observed value at baseline. Productivity affected while working is estimated on a 0 (no effect) to 10 scale (completely preventing productivity).