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Table 1 Baseline characteristics of DA-naive and DA-exposed patients (mITT population)

From: Effect of prior exposure to dopamine agonists on treatment with gabapentin enacarbil in adults with moderate-to-severe primary restless legs syndrome: pooled analyses from 3 randomized trials

Characteristic

DA-naive (n = 539)

DA-exposed (n = 132)

Placebo (n = 194)

GEn 600 mg

GEn 1200 mg (n = 131)

Placebo (n = 50)

GEn 600 mg (n = 30)

GEn 1200 mg (n = 52)

Age at screening, mean years (SD)

48.9 (12.78)

47.2 (12.85)

49.8 (11.99)

50.5 (10.33)

52.4 (11.26)

54.2 (14.40)

Sex, n (%)

      

  Female

122 (63)

75 (57)

122 (57)

29 (58)

21 (70)

31 (60)

  Male

72 (37)

56 (43)

92 (43)

21 (42)

9 (30)

21 (40)

Race, n (%)

      

  White/Caucasian

186 (96)

123 (94)

206 (96)

48 (96)

29 (97)

50 (96)

Mean baseline IRLS Rating Scale total score, points (SD)

22.5 (4.76)

23.2 (4.98)

22.9 (5.07)

25.2 (4.72)

24.0 (5.34)

24.6 (5.28)

Mean IRLS Rating Scale total score, n (%)

      

  <24 at baseline

116 (60)

67 (51)

126 (59)

18 (36)

14 (47)

21 (40)

  ≥24 at baseline

78 (40)

64 (49)

88 (41)

32 (64)

16 (53)

31 (60)

Duration of RLS symptoms, years

      

  Mean (SD)

13.1 (12.29)

12.5 (12.82)

13.9 (13.33)

17.0 (15.13)

17.9 (12.09)

16.1 (16.80)

Prior RLS treatment, n (%)

      

  Yesa

39 (20)c

20 (15)c

31 (14)c

50 (100)

30 (100)

52 (100)

Prior dopamine agonist treatment, n (%)

      

  Ropinirole

N/A

N/A

N/A

39 (78)

26 (87)

38 (73)

  Pramipexole

N/A

N/A

N/A

9 (18)

5 (17)

10 (19)

  Levodopa-carbidopab

N/A

N/A

N/A

7 (14)

2 (7)

4 (8)

  Rotigotine

N/A

N/A

N/A

2 (4)

2 (7)

2 (4)

  Pergolide mesylate

N/A

N/A

N/A

1 (2)

0

0

  Levodopab

N/A

N/A

N/A

0

0

1 (2)

  1. aIncludes patients whose treatment terminated prior to the month before the start of study drug, and those who received treatment within the month of the start of study drug or within the previous month. bClassified as dopaminergic agents. Patients with a past history of treatment with levodopa-carbidopa and levodopa were included in the DA-exposed group. cExamples of non-DA prior treatment include: gabapentin, non-steroidal anti-inflammatory drugs, zolpidem, diphenhydramine HCL, clonazepam, diazepam, trazodone, tramadol, propoxyphene, cyclobenzaprine, and quinine. Please note, these treatments are not FDA approved treatments for primary moderate-to-severe RLS and list is not inclusive of all prior treatments reported.
  2. DA, dopamine agonist; GEn, gabapentin enacarbil; IRLS, International Restless Legs Syndrome; mITT, modified intent-to-treat; N/A, not available; RLS, restless legs syndrome; SD, standard deviation.
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Journal of Clinical Movement Disorders

ISSN: 2054-7072

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