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Table 3 Absolute mean changes in the development index of the MP-R scale at week 16 and Sequential Analysis

From: A randomized placebo controlled clinical trial to evaluate the efficacy and safety of minocycline in patients with Angelman syndrome (A-MANECE study)

Secondary analysis: Absolute mean changes in the DI (age equivalent in months) of the MP-R Scale

Age equivalents (months)

 

Group A (Placebo-Minocycline) (N = 11)

Group B1 (Minocycline-Placebo) (N = 11)

Group B2 (Minocycline-Minocycline) (N = 10)

p value

Development index

Baseline

12·55 (6·53)

13·09 (6·31)

10·80 (6·33)

0·699

Week 16

15·55 (5·93)

13·90 (6·65)

12·00 (7·64)

0·495

Absolute mean change

3·00 (3·63)

0·72 (2·56)

1·20 (5·53)

0·401

Secondary analysis: Development index change after 8 week or 16 week total treatment duration with minocycline

Age equivalents(months)

 

Minocycline 8 weeksa (N = 22)

Minocycline-16 weeksb (N = 10)

 

Absolute mean differences, 95% CI

Development index

Absolute mean change

1·86 (3·35)

1·20 (5·53)

 

0·663, 95% CI (−2·55–3·88)

Secondary analysis: Period effect analysis in the cross-over substudy

  

PERIOD 1 (N = 22)

PERIOD 2 (N = 22)

 

Absolute mean differences, 95% CI, p value

Development index

Absolute mean change

2·21 (3·37)

− 0·34 (3·24)

 

2·55, 95% CI (0·80–5·05)

  1. a Minocycline treatment for 8 weeks include Group A and Group B1 mean changes at week 16 following a total 8-week treatment duration, regardless of the actual placebo-minocycline sequence of treatment;
  2. b This corresponds to mean changes at week 16 for Group B2, the subset of 10 patients who received a total of 16 weeks treatment with minocycline