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Table 4 Mean changes in ADHD RS-IV-J:I over time for all treatment groups (FAS)

From: Using the drug repositioning approach to develop a novel therapy, tipepidine hibenzate sustained-release tablet (TS-141), for children and adolescents with attention-deficit/hyperactivity disorder

 

Placebo

TS-141 30 mg

TS-141 60 mg

TS-141120 mg

(N = 52)

(N = 54)

(N = 52)

(N = 53)

ADHD RS-IV-J:I

  

Difference with placebo

 

Difference with placebo

 

Difference with placebo

Start of the study (Mean ± SD)

34.7 ± 6.4

33.4 ± 7.4

–

34.9 ± 7.1

–

32.3 ± 5.8

–

Change from Baseline (Point estimate [95%CI] (p-value))

 Week 2

−3.8 [−5.6 - -2.1]

− 3.6 [− 5.3 - -1.9]

0.2 [− 1.8–2.2]

(p = 0.830)

−3.1 [− 4.9 - -1.3]

0.7 [−1.3–2.7]

(p = 0.488)

−4.2 [− 5.9 - -2.4]

−0.3 [− 2.3–1.7]

(p = 0.735)

 Week 4

−6.0 [− 8.4 - -3.6]

−4.7 [− 6.9 - -2.5]

1.3 [−1.3–3.8]

(p = 0.321)

−3.9 [− 6.2 - -1.5]

2.1 [−0.4–4.7]

(p = 0.104)

−6.2 [− 8.5 - -3.9]

−0.2 [− 2.8–2.3]

(p = 0.849)

 Week 8

−9.1 [− 11.9 - -6.2]

−6.9 [− 9.6 - -4.2]

2.2 [− 0.8–5.2]

(p = 0.158)

−5.4 [− 8.1 - -2.6]

3.7 [0.6–6.7]

(p = 0.018)

−9.0 [− 11.7 - -6.3]

0.0 [− 3.0–3.0]

(p = 0.986)

 End of the study

−8.0 [− 10.6 - -5.4]

− 6.0 [− 8.5 - -3.5]

2.0 [− 0.9–4.8]

(p = 0.183)

−4.9 [− 7.5 - -2.3]

3.1 [0.2–6.0]

(p = 0.037)

−8.5 [− 11.0 - -5.9]

− 0.5 [− 3.4–2.4]

(p = 0.748)

  1. p ANCOVA with baseline and CYP2D6 phenotype as covariates