Phase III study of MG01CI for ADHD shows significant improvement - Alcobra

Alcobra has announced topline results from a Phase III study of MG01CI (metadoxine extended release (MDX)) in adults with Attention Deficit Hyperactivity Disorder (ADHD). In a modified Intent To Treat (mITT) population (n=293), MDX demonstrated a statistically significant improvement in ADHD symptoms compared to placebo as measured by the Conner's Adult ADHD Rating Scale (CAARS-INV). In the mITT analysis, there was a mean change on the CAARS-INV from baseline to the final visit of 11.6 in the MDX treated group as compared with a mean change of 8.7 in the placebo treated group. MDX also showed a statistically significant impact on the inattention subscale of the CAARS-INV.

Patients with both predominately inattentive (PI) ADHD and combined type (CT) ADHD subtypes appeared to benefit similarly in this trial. MDX was well tolerated during the trial. The number of patients reporting adverse events was similar between the MDX and placebo groups with no drug-related serious adverse events reported. The most common adverse events seen in the study were headache (15.1% in MDX group vs. 12.3% in placebo group), nausea (8.6% vs. 6.2%), and fatigue (7.2% vs. 8.2%). Detailed results of the study will be made available at scientific and medical conferences in the coming weeks.