Randomized clinical trial of low dose suramin intravenous infusions for treatment of autism spectrum disorder

Table 2 Modeled efficacy results comparing active treatments with placebo

Dose Group (n)	ABC-Core^a	ABC-Total^a	CGI-I Question 1^bc	CGI-I 24 item^bc	ATEC^ac
10 mg/kg (13)
Mean change from BL ± SE	− 12.3 ± 3.25	− 32.0 ± 6.88	2.8 ± 0.30	73.4 ± 5.57	− 20.9 ± 4.09
Difference from placebo:
Mean change from BL (95% CI)	− 3.9 (− 13.9, 6.1)	− 14.7 (− 35.8, 6.3)	1.1 (0.2, 2.0)	21.2 (4.2, 38.3)	− 4.3 (− 17.5, 9.0)
P value, unadjusted	0.37	0.12	0.008	0.007	0.46
P-value, adjusted^d	0.58	0.20	0.016	0.013	0.68
20 mg/kg (14)
Mean change from BL ± SE	− 6.5 ± 2.89	− 16.2 ± 6.13	2.0 ± 0.28	59.5 ± 5.11	− 15.2 ± 4.04
Difference from placebo:
Mean change from BL (95% CI)	2.0 (− 7.5, 11.4)	1.1 (− 18.9, 21.0)	0.3 (− 0.6, 1.2)	7.3 (− 9.1, 23.7)	1.5 (− 12.0, 14.9)
P value, unadjusted	0.64	0.90	0.43	0.31	0.80
P-value, adjusted^d	0.85	0.99	0.65	0.50	0.96
Placebo (14)
Mean change from BL ± SE	− 8.4 ± 2.91	− 17.3 ± 6.17	1.7 ± 0.27	52.2 ± 4.99	− 16.6 ± 4.07

ABC-Core aberrant behavior checklist of core symptoms, ABC-Total, aberrant behavior checklist—total score, ATEC autism treatment evaluation checklist, BL baseline, CGI-I question 1, clinical global impression of improvement question 1 overall severity of symptoms, CGI-I 24 item, summary score of clinical global impression of improvement for all 24 items; CI Confidence Interval, SE standard error
^aNegative score indicates improvement
^bPositive score indicates improvement
^cNominal p-values
^dVia Dunnett’s method

ISSN: 1744-859X