September 9, 2011 — In adults with attention-deficit hyperactivity disorder (ADHD), an extended-release formula of metadoxine, MG01C1, improved total ADHD symptoms scores compared with placebo, according to the results of a randomized phase 2 trial.
Teva Pharmaceutical Industries Ltd and Alcobra Ltd announced topline results in a press release on September 7.
Metadoxine is a nonstimulant 5-hydroxytryptamine receptor antagonist. The immediate-release formulation is currently used to treat acute alcohol intoxication and withdrawal symptoms in adults.
A previous phase 1 trial established safety after 1 dose of MG01C1 in adults with ADHD. The phase 2 trial was designed to determine safety and efficacy in 120 patients randomly assigned in a 1:1 ratio to receive 1400 mg of MG01C1 or placebo for 6 weeks.
Patients participated in up to a 2-week screening period before treatment and a 2-week follow-up after treatment. Standard ADHD tools, such as the Conners' Adult ADHD Rating Scale-Investigator Rated Total ADHD Symptoms Score (CARRS-INV), Adult ADHD Quality of Life Scale (AAQoL), Clinical Global Impression (CGI) scale, and Test of Variables of Attention (TOVA), were used to evaluate ADHD symptoms.
A significant improvement of at least 25% in CAARS-INV scores was observed in 56% of patients receiving MG01C1 compared with 36% of patients in the control group (P < .03). CAARS-INV score improvement of more than 40% was seen in 44% of patients in the MG01C1-treated group compared with 25% of patients receiving placebo (P < .04).
The secondary efficacy endpoints, the AAQoL and TOVA scales, were also significantly improved in the MG01C1 group.
The most common adverse effects were nausea and initial insomnia, which occurred more frequently in the MG01C1 group. The 1.7% discontinuation rate was similar in both groups of the trial. Increased blood pressure and decreased appetite were not observed in patients receiving MG01C1.
"MG01CI may have a quick onset of activity with few side effects, distinguishing it from other non-stimulant ADHD treatments," Yaron Daniely, PhD, MBA, chief executive officer of Alcobra, stated in the press release. "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."
The phase 2 trial was funded by Alcobra, Ltd.
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