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Table 1 Baseline demographic and characteristics of enrolled subjects from two clinical trials conducted in subjects with primary RLS

From: Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials

Characteristic

XP052

(n = 220)

XP053

(n = 320)

All

(n = 540)2

Age

   

   Mean (SD)

51.5 (12.75)

49.3 (12.55)

50.2 (12.66)

Female (n, %)

131 (59.5%)

189 (59.1%)

320 (59.3%)

Race (n, %)

   

   White or Caucasian

212 (96.4)

303 (94.7)

515 (95.4)

   Black or African-American

5 (2.3)

5 (1.6)

10 (1.9)

   Other

3 (1.3)

12 (3.7)

15 (2.7)

Ethnicity (n, %)

   

   Hispanic or Latino

8 (3.6)

25 (7.8)

33 (6.1)

   Non-Hispanic or Latino

212 (96.4)

295 (92.2)

507 (93.9)

Treatment (n, %)

   

   1200 mg

113 (51.4)

111 (34.7)

224 (41.5)

   600 mg

0

113 (35.3)

113 (20.9)

   Placebo

107 (48.6)

96 (30.0)

203 (37.6)

RLS Severity (n, %)1

   

   Mild

0

0

0

   Moderate

82 (37.3)

102 (31.9)

184 (34.1)

   Severe

121 (55.0)

193 (60.3)

314 (58.1)

   Very severe

17 (7.7)

25 (7.8)

42 (7.8)

  1. RLS, Restless Legs Syndrome; SD, standard deviation.
  2. 1RLS Disease Severity based on International Restless Legs Rating Scale Total Score, where mild = 0-10, moderate = 11-20, severe = 21-30, and very severe >30.
  3. 2In the original clinical trials; there were a total of 544 subjects. In this study we used the Post Sleep Questionnaire (PSQ) validation sample, which includes only those who completed the PSQ at Baseline (N = 540) and Week 12 (N = 451).