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news.Israel-based pharmaceutical firm Alcobra has completed all scheduled follow-up visits for patients enrolled in its Phase III clinical trial of metadoxine extended release (MDX) to treat in adult attention deficit hyperactivity disorder (ADHD) patients.
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The company is focused on the development of new medications to help patients with cognitive disorders, including ADHD and Fragile X Syndrome.
The 300-patient, randomized, placebo-controlled trial was conducted at 18 sites in the US and two in Israel.
Alcobra president and chief executive officer Yaron Daniely said: "Completion of this Phase III clinical trial is a major milestone in the development of MDX, as we are one step closer to a potential new treatment alternative for Adult ADHD.
"We currently anticipate completing data verification in this multi-center trial, database lock and topline statistical analysis in approximately two weeks. We look forward to unblinding the data and announcing the results."
In the trial, patients were given either 1400mg MDX or placebo over six weeks followed by a two-week safety follow-up and preceded by 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, and the same endpoint used in the company’s successful Phase IIb trial.
The trial’s secondary endpoints include the computerized Test of Variables of Attention (TOVA), which was also used in the previous Phase II studies, as well as safety assessments and additional exploratory endpoints.