Alcobra Announces Enrollment of First Patient in Phase IIb Clinical Trial of MDX in Adolescents With ADHD
TEL AVIV, Israel, Sept. 2, 2014 (GLOBE NEWSWIRE) -- Alcobra Ltd. (ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that the first patient has been enrolled in a Phase IIb study of MDX in adolescents with ADHD. The trial is expected to complete enrollment and report topline data by the end of 2014.
The Phase IIb trial is a multi-center, randomized, double-blind, fixed dose study designed to evaluate the safety and tolerability of MDX in up to 82 adolescents (aged 13-17) with predominantly inattentive ADHD (PI-ADHD). The primary endpoint will be safety, tolerability and pharmacokinetics. Secondary endpoints include change in efficacy measures such as TOVA (Test of Variables of Attention), Wechsler Intelligence Scale for Children (WISC-IV) subtests, and working memory and processing speed. ClinicalTrials.gov Identifier: NCT02189772
