Alcobra Completes Patient Recruitment in Phase III Clinical Trial of MDX in Adult ADHD
GlobeNewswire Alcobra Ltd.
TEL AVIV, Israel, July 14, 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 recruitment of patients has been completed in the Company's Phase III clinical trial of Metadoxine Extended Release (MDX) in adult ADHD patients.
"I would like to thank all the patients who participated in the trial, as well as the professional work by our investigators who quickly and rigorously enrolled patients in less than four months," said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. "We look forward to all patients completing the study protocol, and reporting the topline results later this quarter."
The study is a 300-patient, randomized, placebo-controlled trial conducted at 18 sites in the United States and 2 in Israel. Patients were 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 include the computerized TOVA (Test of Variables of Attention), which was also used in the previous Phase 2 studies, as well as safety assessments and additional exploratory endpoints.
"We are pleased we have reached this important milestone in the execution of the trial," said Dr. Richard Weisler, Principal Investigator of the study, adjunct professor of psychiatry at the University of North Carolina School of Medicine and adjunct associate professor of psychiatry at Duke University Medical Center. "There remain substantially unmet needs in the management of adult ADHD and this trial, when completed, will provide important clinical information to the medical community."
As previously announced, Alcobra will host an Investor Forum on Tuesday, July 15, 2014 from 8am-9:30am Eastern Time in New York City. Management will provide an update on the ongoing development program for MDX. Dr. Craig Surman, MD, an expert in the management of adult ADHD will offer insights into the diagnosis and management of adult ADHD, and current therapeutic options and unmet medical needs in ADHD. Alcobra's executive management team will provide an evidence-based overview of the commercial potential for its lead product, Metadoxine Extended Release (MDX), in ADHD based on recently completed primary and secondary research and analysis.
The presentations, followed by a question-and-answer session, will be webcast live beginning at 8am Eastern Time. The webcast and accompanying presentation materials will be accessible live and archived on the Investor Relations section of Alcobra's website at www.alcobra-pharma.com.
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