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news.Teva Pharmaceutical and Alcobra's Phase II trial of MG01CI in adults with attention deficit hyperactivity disorder (ADHD) has met primary efficacy.
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The results from a placebo-controlled, randomized, six-week Phase II study demonstrated improvement on the Conners’ Adult ADHD Rating Scale-Investigator Rated Total ADHD Symptoms Score (CAARS-INV) compared to placebo.
In the trial, around 56% of the patients treated with MG01C showed improvement in their CAARS-INV score of at least 25%, compared to 36% of patients in the placebo group.
Additionally, 44% of the patients treated with MG01CI showed an improvement of more than 40% their CAARS-INV score versus only 25% in the placebo group.
Alcobra CEO Yaron Daniely said these results confirm previous clinical experience indicating MG01CI may have a quick onset of activity with few side effects, distinguishing it from other non-stimulant ADHD treatments.
"Based on the positive results of this Phase II trial and the high unmet need for novel ADHD treatments, we intend to commence Phase III studies in adults in 2012 and later on in children," Daniely said.