$ADHD,...Alcobra Pharma announces topline results from Phase III study of MDX in adult ADHD
Co announced topline results from a Phase III study of Metadoxine Extended Release in adults with ADHD. In a modified Intent To Treat population, MDX demonstrated a statistically significant improvement in ADHD symptoms compared to placebo as measured by the Conner's Adult ADHD Rating Scale.
The mITT population was derived by a post hoc exclusion of four subjects with extreme placebo responses (The ITT analysis before exclusion yielded a positive trend, p=0.15; n=297).
The primary endpoint was the CAARS-INV, a widely accepted clinical measure of the presence and severity of ADHD symptoms, which has been utilized in registration studies for other approved ADHD drugs.
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