Israel-based biopharmaceutical firm Alcobra has initiated patient enrolment in a Phase III clinical trial of its proprietary drug candidate Metadoxine Extended Release (MDX) for the treatment of adults with attention deficit hyperactivity disorder (ADHD).
The move follows the recent acceptance of Alcobra’s investigational new drug application (IND) for MDX by the US Food and Drug Administration (FDA).
About 300 patients are expected to be enrolled in the randomised, placebo-controlled trial, which will be conducted at 20 sites in the US and Israel.
In the trial, patients will be given either 1,400mg MDX or placebo over six weeks following a two week screening period.
Primary endpoint of the trial is the Conners’ Adult ADHD Rating Scale (CAARS-INV), a widely accepted clinical measure of the presence and severity of ADHD symptoms.
The trial’s secondary endpoints will include the computerised TOVA (Test of Variables of Attention) which was also used in the previous Phase II studies, as well as additional exploratory endpoints.
Alcobra president and chief executive officer Yaron Daniely said the company is happy to have its US clinical programme for MDX underway with the enrolment of the first patient in the clinical trial.
"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," Daniely said.
According to the company, the Phase III trial of MDX is expected to be completed in the second half of 2014.
The University of North Carolina School of Medicine adjunct professor of psychiatry and principal investigator of the trial Richard Weisler said the trial should give them important insights into the efficacy and safety of MDX in ADHD.
"Up to 60% of people who have ADHD as children will continue to have significant ADHD symptoms that persist into adulthood," Weisler said.
"There remains a significant unmet need for additional treatments that are safe, effective, and preferably for many patients, non-addictive."
The company said that MDX had showed significant efficacy and was generally well tolerated in two separate placebo-controlled Phase II trials in adults with ADHD.
Alcobra is focused in the development and commercialisation of MDX to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome.