Alcobra: First Patient Enrolled In Phase 3 Trial For MDX In Adult ADHD

(RTTNews) - Alcobra Ltd. (ADHD) announced that, following the recent FDA acceptance of the Company's IND for Metadoxine Extended Release, the first patient has been enrolled in a Phase 3 clinical trial of MDX in the treatment of Adults with ADHD.

Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX (Metadoxine Extended Release (MG01CI)), to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder or ADHD and Fragile X Syndrome.

"Building upon our two successful Phase II placebo-controlled studies, this Phase III study is designed to confirm MDX as a fast-acting, highly effective and well tolerated non-scheduled ADHD drug candidate. We expect the trial to be completed in the second half of 2014," said Yaron Daniely, President and Chief Executive Officer of Alcobra.

The study is a 300-patient, randomized, placebo-controlled trial to be conducted at 20 sites in the United States and Israel. Patients will be randomized to receive either 1400 mg MDX or placebo over 6 weeks following a 2 week screening period.

The primary endpoint is the Conners' Adult ADHD Rating Scale (CAARS-INV), a widely accepted clinical measure of the presence and severity of ADHD symptoms. Secondary endpoints will include the computerized TOVA (Test of Variables of Attention) which was also used in the previous Phase 2 studies, as well as additional exploratory endpoints.