ARTICLE | Clinical News

Alcobra hammered on intent-to-treat in ADHD

October 7, 2014 2:24 AM UTC

Alcobra Ltd. (NASDAQ:ADHD) closed down $7.99 (57%) to $6.12 on Monday after Metadoxine ER ( MDX), its extended-release formulation of metadoxine, only met the primary endpoint in a Phase III trial to treat adults with ADHD when four patients receiving placebo were excluded from its analysis.

In the 297-patient U.S. and Israeli trial, 1400 mg of the selective antagonist of the serotonin (5-HT2B) receptor failed to improve scores significantly on the Conner's Adult ADHD Rating Scale (CAARS-INV) compared to placebo (p=0.15). However, the company said a statistically significant difference was seen in a modified intent-to-treat (mITT) analysis when four exceptional responders were removed from the placebo group. ...