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# FDA Clinical Hold on Alcobra ADHD Trial
- URL: https://www.fdaweb.com/fda-clinical-hold-on-alcobra-adhd-trial/
- Published: 2016-09-29T12:00:00.000Z
- Updated: 2026-09-14T21:35:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136943

FDA has placed a clinical hold on an Alcobra Ltd. clinical trial called MEASURE that is evaluating its investigational drug MDX (metadoxine) extended release for treating adult patients with attention deficit hyperactivity disorder. Alcobra says it has has not yet received written notice of the clinical hold from the agency, however, based on verbal communications, the hold is due to adverse neurological findings in a pre-clinical study. “The FDA notification was not based on clinical safety data observed in the ongoing MEASURE study, which has enrolled nearly 500 subjects, or previous clinical studies involving MDX,” it says.

In contrast to available treatments, MDX is a not a stimulant and shows no signs of abuse or addiction, Alcobra says. “It has a differentiated mechanism of action that targets neither dopamine nor norepinephrine,” the company says. “Our two Phase II placebo-controlled studies showed significant clinical improvement in clinical symptoms with high response rates and a rapid onset of action. The trials also demonstrated favorable tolerability.”