NYC Healthcare News



Targacept commences Phase 2 clinical proof of concept trial of TC-5619 in adults with ADHD

September 15, 2015

The multi-center Phase 2 clinical proof of concept ADHD trial is a double-blind, placebo controlled, randomized, parallel group study being conducted in the United States. The trial is planned to enroll up to 125 patients ages 18 to 65. As with Targacept's ongoing Phase 2 clinical proof of concept trial of TC-5619 in cognitive dysfunction in schizophrenia (CDS), the trial design provides for patients to be randomly assigned to one of two cohorts, TC-5619 or placebo, and dosed over a 12-week period. Patients randomized to the TC-5619 arm will be up-titrated every four weeks and tested on each of three doses of TC-5619. The primary efficacy outcome measure of the trial is change from baseline on the Conners Adult ADHD Rating Scale, a multimodal questionnaire assessment of symptoms and behaviors associated with ADHD in adults aged 18 and older.

The ADHD trial is part of a recently expanded development program for TC-5619 that also includes Targacept's ongoing Phase 2 clinical proof of concept trial in CDS and other studies planned to be conducted by each of Targacept and its strategic collaborator AstraZeneca to support the potential advancement of TC-5619 into Phase 2 clinical development for Alzheimer's disease. AstraZeneca has the future right to license TC-5619 for various cognitive disorders under the parties' December 2005 collaboration agreement.

SOURCE Targacept