Clinical Trials Resource Center

New Medical Therapies™

Generalized Anxiety Disorder (GAD)

Patient Medical Areas

January 14, 2008

Addex issued negative results from a phase IIa trial of ADX10059 for the treatment of acute anticipatory anxiety. This double-blind, placebo-controlled trial enrolled fifty subjects in the United Kingdom. All subjects were undergoing a routine dental procedure and presented with moderately severe anxiety. The subjects received a single 250 mg dose of ADX10059 or placebo sixty minutes prior to the procedure. The primary endpoint was a reduction on the Visual Analog Scale of anxiety (VAS anxiety) sixty minutes after dosing (immediately prior to the start of the dental procedure). Anxiety was measured at specific time points before, during and after the procedure. The results did not show a statistical difference between ADX10059 and placebo (mean VAS 4.81 cm compared to 4.67 cm, respectively). Based on the results, Addex did not announce plans to move forward with ADX10059 for this indication.

August 22, 2005

Predix reported positive results of a phase II trial of PRX-00023, their investigational 5-HT1A agonist, for the treatment of generalized anxiety disorder (GAD). Results demonstrated a positive overall safety profile, with no serious adverse events or drug related adverse events leading to discontinuation. The most common overall adverse event was flu-like symptoms. Secondary efficacy data produced preliminary improvements on the HAM-A, CGI-Global Improvement, and Hospital Anxiety and Depression diagnostic scales. This open-label, multi-center study enrolled 20 patients with moderate-to-severe GAD, who received sequential ascending dose regimens of the drug after a 1 week placebo run-in: subjects received 40 mg once daily for 4 days, then 80 mg once daily for 10 days, then 120 mg once daily for 14 days.

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