Table 1 Demographics and Baseline Disease Characteristics

From: Effect of the mGluR5-NAM Basimglurant on Behavior in Adolescents and Adults with Fragile X Syndrome in a Randomized, Double-Blind, Placebo-Controlled Trial: FragXis Phase 2 Results

 

Placebo ( n =63)

Basimglurant 0.5 mg ( n =58)

Basimglurant 1.5 mg ( n =62)

Age in years

23.7 (8.0)

22.4 (7.6)

24.2 (9.5)

Sex, n (%)

 Male

51 (81%)

48 (83%)

50 (81%)

 Female

12 (19%)

10 (17%)

12 (19%)

Weight at screening in kg

73.6 (18.8)

73.5 (15.9)

75.3 (16.3)

ADAMS total

30.7 (15.3)

26.7 (15.9)

25.6 (12.6)

ABC total

51.5 (27.0)

48.1 (30.7)

46.5 (27.0)

CGI-S

4.3 (1.1)

4.5 (1.0)

4.3 (1.1)

SRS T-Score

80.4 (13.8)

78.2 (11.7)

78.1 (12.9)

VABS-II Adaptive Behavior Composite Standard Scores

49.6 (20.1)

49.2 (25.9)

55.6 (34.6)

CBI-M

25.68 (16.90)

28.98 (19.59)

22.89 (13.30)

ADOS Module 2, n (%)

 Autism

10 (77%)

11 (79%)

11 (73%)

 Autism Spectrum Disorder

3 (23%)

1 (7%)

1 (7%)

 Nonspectrum

0

2 (14%)

3 (20%)

ADOS Modules 3 and 4, n (%)

 Autism

24 (50%)

25 (63%)

27 (64%)

 Autism Spectrum Disorder

2 (4%)

5 (13%)

5 (12%)

 Nonspectrum

22 (46%)

10 (25%)

10 (24%)

VAS most troublesome behavior coded term a

 Anxiety disorders and symptomsb

10 (15.9%)

11 (19.0%)

11 (17.7%)

 Behavior and socialization disturbancesc

18 (28.6%)

19 (32.8%)

16 (25.8%)

 Changes in physical activity

1 (1.6%)

1 (1.7%)

2 (3.2%)

 Cognitive and attention disorders

0

2 (3.4%)

2 (3.2%)

 Communication disorders

10 (15.9%)

8 (13.8%)

11 (17.7%)

 Developmental delayd

3 (4.8%)

6 (10.3)

3 (4.8%)

 Mood disorder and disturbances NECe

4 (6.3%)

1 (1.7%)

3 (4.8%)

 Social avoidant behavior and social phobia

14 (22.2%)

8 (13.8%)

11 (17.7%)

 Not applicablef

2(3.2%)

1 (1.7%)

1 (1.6%)

 Otherg

1 (1.6%)

1 (1.7%)

2 (3.2%)

  1. A higher ADAMS, ABC, CGI-S, SRS and CBI-M score indicates more severe behavioral symptoms. A lower VABS-II score indicates more impaired adaptive behavior. All data are presented as mean (SD) unless specified.
  2. aMost troubling symptom coded term is the MedDRA Higher Level Group Term unless otherwise specified.
  3. bAnxiety disorders and symptoms excludes social phobia.
  4. cBehavior and socialization disturbances was used in place of the Higher Level Group Term and includes impulsive behavior and sexually inappropriate behavior and excludes social avoidant behavior.
  5. dDevelopmental delay was used in place of the Higher Level Group Term.
  6. eMood disorders and disturbances NEC includes depression.
  7. fNot applicable includes no specific behavior concern or assessment not completed.
  8. gOther includes enuresis, perseveration, autism, and eating disorder symptom NOS.
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