The primary endpoint of the trial was defined as change from baseline on the Conners’ Adult ADHD Rating Scale-Investigator Rated Total ADHD Symptoms score (CAARS-INV) after four, eight and 12 weeks of dosing, as compared to placebo.
The trial also included a number of assessments as secondary efficacy outcome measures, and results across all of these assessments indicated that TC-5619 had activity in the patient population.
For secondary efficacy outcome measures, TC-5619 outperformed placebo with statistical significance approximately seven times more often than placebo outperformed TC-5619 by the same standard.
TC-5619 was generally well tolerated in the trial, without any serious adverse events.
The double blind, placebo controlled, forced titration Phase 2 trial was conducted at 17 sites in the US.
The trial involved 135 non-tobacco using patients, age 18 to 65, meeting DSM-IV criteria for ADHD, who were randomised to receive either TC-5619 or placebo for 12 weeks.
TC-5619, a highly selective alpha7 neuronal nicotinic receptor modulator, is subject to license by Targacept’s strategic partner AstraZeneca.