Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD (continued)
Study
Inclusion/ Exclusion Baseline
Description Intervention
Criteria/ Population Measures Outcomes
within 60 days prior to
trend: P = 0.52
screening visit
Responders to
• IgA deficiency (serum
treatment, MGIS,
IgA < 5 mg/dl)
CE population, n:
• A history of severe
G1a: 9/20
hypersensitivity to
G1b: 6/20
human immunoglobulin
G1c: 8/20
• Treatment with any
G2: 10/22
human immunoglobulin
G1/G2: P = NR
and/or immunoglobulin
(“similar to ITT
products within 90 days
population”)
prior to screening visit
Dose-response
• Concurrent medication
that would compromise
tolerance of drug or
compliance with the
protocol
Additional exclusion
criteria during screening:
• Clinically significant
abnormal laboratory test
values
• Failure of parent or
guardian to record at
least 11/14 days of daily
diary assessments or the
weekly assessments
• GI Symptoms Score of <
5 for week 1 or 2 of the
screening period
• MGIS score moderately
or substantially improved
during week1 or 2 of the
screening period
• Parent or guardian’s
inability or unwillingness
to follow directions or
inability to understand
how to use the electronic
diary data entry system
Age, years ± SD (range):
G1a: 7.4 ± 3.1 (3-13)
G1b: 8.0 ± 4.1 (2-17)
G1c: 7.6 ± 3.5 (3-13)
G2: 6.2 ± 3.3 (2-14)
trend: P = 0.59
Medical:
Responders to
treatment by
predominant
bowel pattern, n:
Diarrhea:
G1a: 3/11
G1b: 2/9
G1c: 6/15
G2: 5/14
Dose-response
trend: P = 0.69
Constipation:
G1a: 7/20
G1b: 7/20
G1c: 3/11
G2: 7/12
Dose-response
trend: P = 0.22
Alternating:
G1a: 1/1
G1b: 0/2
G1c: 2/5
G2: 2/5
Dose-response
trend: P = 0.79
Handen, et al.,
Age, n (%):
Responders to
2009 (continued)
2-11 years:
treatment with
G1a: 28 (87.5)
regression-onset
G1b: 27 (87.1)
of autistic
G1c: 27 (87.1)
symptoms, n
G2: 27 (87.1)
G1a: 6/18
12-17 years:
G1b: 7/20
G1a: 4 (12.5)
G1c: 9/21
G1b: 4 (12.9)
G2: 9/21
G1c: 4 (12.9)
Dose-response
G2: 4 (12.9)
trend: P = 0.85
Mental age:
Responders to
C-48