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Table 1 Baseline characteristics

From: A randomized, double-blind, placebo-controlled phase II trial to explore the effects of a GABAA-α5 NAM (basmisanil) on intellectual disability associated with Down syndrome

 

Placebo

Basmisanil

120 mg (80 mg)

240 mg (160 mg)

n = 58

n = 55

n = 57

Age (years)

 Mean ± SD

18.7 ± 5.2

18.3 ± 4.9

18.7 ± 5.4

 Median

18.0

17.0

17.0

 Minimum to maximum

12–30

12–28

12–29

 12–17 years: n (%)

28 (48%)

28 (51%)

29 (51%)

 18–30 years: n (%)

30 (52%)

27 (49%)

28 (49%)

Sex

 Males: n (%)

33 (57%)

32 (58%)

38 (67%)

 Females: n (%)

25 (43%)

23 (42%)

19 (33%)

Ethnicity

 Hispanic or Latino: n (%)

11 (19.0%)

13 (23.6%)

10 (17.5%)

 Not Hispanic or Latino: n (%)

38 (65.5%)

35 (63.6%)

39 (68.4%)

 Unknown: n (%)

9 (15.5%)

7 (12.7%)

8 (14.0%)

Race: n (%)

 American Indian or Alaska Native

1 (1.7%)

0

0

 Asian

1 (1.7%)

1 (1.8%)

0

 Black or African American

0

2 (3.6%)

0

 Multiple: White/Asian

2 (3.4%)

0

0

 White

45 (77.6%)

44 (80.0%)

49 (86.0%)

 Unknown

9 (15.5%)

8 (14.5%)

8 (14.0%)

Formulationa

 Granules: n (%)

10 (17%)

10 (18%)

12 (21%)

 Tablets: n (%)

48 (83%)

45 (82%)

45 (79%)

CGI-severity

 Mean ± SD

3.7 ± 1.0

3.8 ± 0.9

3.9 ± 0.9

 Median

4.0

4.0

4.0

 Minimum to maximum

1–5

1–5

1–6

 ≤ 3: n (%)

18 (31%)

16 (31%)

12 (22%)

 > 3: n (%)

40 (69%)

36 (69%)

43 (78%)

CELF-4 (word classes 1): mean ± SD

 Receptive

15.2 ± 4.3

15.2 ± 3.9

14.7 ± 4.9

 Expressive

9.7 ± 5.4

9.6 ± 4.2

9.8 ± 5.1

CELF-4 (word classes 2): mean ± SD

 Receptive

3.5 ± 4.1

2.98 ± 3.4

2.8 ± 3.2

 Expressive

1.8 ± 2.3

1.4 ± 1.7

1.5 ± 1.9

Anxiety/mood (ADAMS): mean ± SD

 Depressed mood

2.5 ± 2.9

2.1 ± 2.0

2.5 ± 3.1

 Anxiety

2.6 ± 2.3

2.5 ± 2.5

2.6 ± 2.9

 Manic/hyperactive

3.2 ± 2.4

4.0 ± 3.1

3.1 ± 2.8

 Obsessive/compulsive

1.9 ± 2.0

1.9 ± 1.8

1.7 ± 1.8

 Social avoidance

3.8 ± 3.9

4.3 ± 3.7

3.8 ± 3.9

IQb

 Mean ± SD

52.8 ± 13.6

55.2 ± 14.6

55.6 ± 13.9

 Median

49

53

57

 Minimum to maximum

32–93

32–93

32–80

  1. Abbreviations: ADAMS Anxiety, Depression and Mood Abnormalities, CELF Clinical Evaluation of Language Fundamentals, CGI Clinical Global Impression, SD standard deviation
  2. aA granule formulation was available for individuals with difficulties swallowing tablets (assessed in comparative bioavailability study WP28978 [NCT02194244])
  3. bIQ assessed by Leiter International Performance Scale-revised: a non-verbal intelligence test
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Journal of Neurodevelopmental Disorders

ISSN: 1866-1955

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