Table e-1: Effect of treatment on primary and secondary endpoints

End Point / Pregabalin
(n = 30)
Mean (SD) / Placebo
(n = 28)
Mean (SD) / Adjusted Absolute difference ITT* (95% CI) / P value
Primary outcome measure
Change IRLS / -12.36 (6.91) / -8.64 (9.45) / -4.92 (-0.73; -9.12) / 0.022
Secondary outcome measures
Change PLMs
PLM-Sleep/hr Index / -13.13 (21.70) / 3.77 (17.88) / .17.29 (-6.96;-27.63) / 0.001
PLM-Arousal/hr Index / -5.88 (13.54) / 1.01 (8.50) / -5.59 (-0.52; -10.66) / 0.031
PLM-Awake/hr Index / -16.08 (42.48) / -1.94 (21.53 / -16.45 (-0.22; -32.69) / 0.047
Change MOS
Sleep problems index I / 1.54 (0.90) / 0.74 (0.86) / 0.98 (0.57; 1.38) / <0.001
Sleep problems index II / 1.27 (0.76) / 0.67 (0.67) / 0.68 (0.34; 1.02) / <0.001
Change STAI
-3.58 (9.58) / .5.83 (9.45) / -3.82 (-8.39; 0.74) / 0.1
Polysomnography (PSG) / Absolute difference PP** (95% CI)
Change total sleep time / 38.00 (98.97) / 7.56 (52.93) / 30.44 (-24.36; 85.24) / 0.268
Change sleep efficiency / 10.14 (19.84) / 4.59 (11.84) / 5.55 (-5.76; 16.86) / 0.326
Change sleep latency / -29,40 (29.64) / -13.10 (34.38) / -19,37 (-45.75;7.02) / 0.146
Change REM latency / -5.43 (60.08) / -19.72 (49.33) / 14.29 (-19.89;48.47) / 0.403
Change % Stage 1 / -2.68 (4.68) / 0.25 (2.91) / -2.93 (-5.40; -0.46) / 0.021
Change Stage 1 (min) / -4.69 (16.97) / -0.30 (10.44) / -4.39 (-13.09; 4.31) / 0.315
Change % Stage 2 / -2.36 (10.85) / 4.64 (8.90) / -7.00 (-13.08; -0.93) / 0.025
Change Stage 2 (min) / 6.08 (67.73) / 18.50 (43.61) / -12.42 (47.70; 22.86) / 0.482
Change % Stage 3 / 3.72 (7.69) / -0.80 (5.31) / 4.52 (0.44; 8.60) / 0.031
Change Stage 3 (min) / 18.58 (35.11) / -2.70 (17.53) / 21.28 (3.84;38.72) / 0.018
Change % Stage 4 / -0.44 (14.02) / -3.03 (7.53) / 2.59 (-4.43; 9.61) / 0.461
Change Stage 4 (min) / 17.58 (19.62) / -5.87 (22.84) / 23.45 (10.54; 36.37) / 0.001
Change % SWS / 3.28 (16.12) / -3.83 (7.91) / 7.11 (-0.84; 15.07) / 0.078
Change SWS (min) / 32.76 ( 37.29) / -8.57 (27.18) / 41.34 (21.24;61.42) / <0.001
Change % Stage REM / -2.70 (10.70) / -0.87 (8.54) / -1.82 (-7.76; 4.11) / 0.538
Scores on the RLS-6
Item 1 (satisfaction with sleep) / 2 (1) / 5 (2) / <0.001
Item 2 (RLS when falling asleep) / 1 (2) / 2 (2) / <0.01
Item 3 (RLS at night) / 1 (2) / 2 (3) / <0.05
Item 4 (RLS during the day at rest) / 1 (2) / 2 (2) / <0.1
Item 5 (RLS during activity) / 0 (0) / 0 (1) / n.s.
Item 6 (daytime sleepiness) / 2 (2) / 3 (3) / n.s.
Total / 7 / 14
*by baseline value intent to treat population
**per protocol population