Alcobra Reports Topline Results From Phase III Trial Of MDX In Adult ADHD

(RTTNews) - Alcobra Ltd. (ADHD) announced topline results from a Phase III study of Metadoxine Extended Release or MDX in adults with ADHD. In a modified Intent To Treat or mITT population, MDX showed a statistically significant improvement in ADHD symptoms compared with placebo as measured by the Conner's Adult ADHD Rating Scale or CAARS-INV. The mITT population was derived by a post hoc exclusion of four subjects with extreme placebo responses.

The 300-patient, randomized, placebo-controlled study was conducted at 18 sites in the U.S. and 2 in Israel. Nearly 70 percent of patients were enrolled in the U.S., and patients were nearly evenly split between men and women. Patients were randomized to receive either 1400 mg of MDX or placebo over 6 weeks. The primary endpoint of the trial 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.

During 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. Also, MDX demonstrated 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.