Table 2 Results in the development index of the MP-R Scale at week 8 (primary endpoint) and specific domains of the MP-R Scale
Age equivalents (months) | PLACEBO (Group A)(N = 11) | MINOCYCLINE Group B)(N = 21) | Absolute mean differences,95% CI | |
|---|---|---|---|---|
Primary analysis: Absolute mean changes in the DI (age equivalent in months) of the MP-R Scale | ||||
Development index | Baseline | 12·55 (6·53) | 12·00 (6·27) | 0·545, 95% CI (−4·29–5·38) |
Week 8 | 14·55 (4·90) | 13·90 (6·06) | 0·641, 95% CI (−3·69–4·97) | |
Absolute mean change | 2·00 (3·28) | 1·90 (3·16) | 0·095, 95% CI (−2·22–2·53) | |
Secondary analysis: Specific domains of the MP-R scale | ||||
Cognition | Baseline | 11·55 (6·18) | 12·76 (6·89) | −1·216, 95% CI (−6·28–3·85) |
Week 8 | 15·09 (5·46) | 14·24 (5·89) | 0·852, 95% CI (−3·50–5·22) | |
Absolute mean change | 3·54 (4·4) | 1·47 (2·22) | 2·069, 95% CI (−0·31–4·44) | |
Fine Motor | Baseline | 12·18 (5·94) | 11·67 (5·78) | 0·515, 95% CI (−3·92–4·95) |
Week 8 | 14·82 (4·30) | 13·71 (5·77) | 1·104, 95% CI (−2·94–5·15) | |
Absolute mean change | 2·63 (4·17) | 2·04 (3·93) | 0·588, 95% CI (−2·46–3·64) | |
Visual Motor Coordination | Baseline | 12·09 (6·42) | 11·29 (6·95) | 0·805, 95% CI (−4·34–5·95) |
Week 8 | 15·55 (4·59) | 16·24 (7·48) | - 0·693, 95% CI (−5·75–4·37) | |
Absolute mean change | 3·45 (4·54) | 4·95 (6·31) | −1·497, 95% CI (− 5·89–2·89) | |
Gross Motor Scale | Baseline | 20·64 (7·90) | 18·81 (6·83) | 1·827, 95% CI (−3·65–7·30) |
Week 8 | 20·64 (5·87) | 20·05 (7·50) | 0·589, 95% CI (−4·73–5·91) | |
Absolute mean change | 0·00 (7·16) | 1·23 (3·20) | −1·238, 95% CI (−4·96–2·48) | |
Socio-emotional | Baseline | 19·09 (13·59) | 18·57 (7·99) | 0·519, 95% CI (−7·24–8·27) |
Week 8 | 15·82 (7·54) | 17·62 (8·26) | -1·801, 95% CI (−7·90–4·30) | |
Absolute mean change | −3·27 (7·48) | −0·95 (7·04) | −2·320, 95% CI (− 7·98–3·14) | |
Adaptive Behavior Scale and Self Care | Baseline | 20·73 (8·69) | 20·29 (6·55) | 0·442, 95% CI (−5·13–6·01) |
Week 8 | 21·73 (9·64) | 21·24 (7·06) | 0·489, 95% CI (−5·60–6·58) | |
Absolute mean change | 1·00 (4·66) | 0·95 (3·42) | 0·047, 95% CI (−2·90–3·00) | |