Arbaclofen in fragile X syndrome: results of phase 3 trials.

This dose group (10 mg TID) at 8 weeks also showed nominally significant improvement (Fig. 4 ) for both the ABC-C FX Irritability subscale ( p = 0.031, effect size 0.51) and the Parenting Stress Index ( p = 0.032, effect size 0.42), and trends toward improvement on the ABC-C FX Hyperactivity subscale ( p = 0.081, effect size 0.44) and the CGI-I ( p = 0.119, effect size 0.43) (Fig. 5a ).

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The CGI-S showed a trend toward improvement over placebo in the arbaclofen group ( p = 0.063) but this was the only measure showing a strong trend, and given the multiple comparisons, this result alone is difficult to interpret as meaningful.

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The primary outcome measure, ABC-C FX Social Avoidance, showed a trend toward improvement that did not reach statistical significance.

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