Cortex undertook this phase IIa clinical trial to assess both the dose of drug required and the effectiveness of CX717 in an adult ADHD population. The primary outcome measure was the ADHD Rating Scale (ADHD-RS) which evaluates both the inattentiveness and hyperactivity symptoms.
The overall ADHD-RS score showed a positive trend in the 800mg twice daily dose group, with a statistically significant effect on the hyperactivity subscale compared to placebo. The 200mg twice daily dose did not show a significant effect however.
CX717 was well tolerated, and there were no serious adverse events or other significant safety concerns with either dose. Furthermore, no increases in blood pressure or heart rate were observed with either dose of CX717.
“The results from this phase IIa study in adults with ADHD show that CX717 provided a clinically relevant response on the ADHD Rating Scale though the results will need to be verified in a larger study,” said Dr Lenard Adler, the lead investigator of the study, director for the Adult ADHD Program, and associate professor of psychiatry and neurology at New York University School of Medicine. “I am encouraged by the performance of CX717 which could lead to the development of a new pharmacotherapy for the treatment of ADHD.”