A poster describing this data was selected as a finalist for the
The Phase 3 CTx-1301-022 study (NCT05631626) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting. The data from the trial, presented at the 2023
'Even with currently available extended-release formulations of dexmethylphenidate, many patients require longer duration of efficacy and must add a second, or booster, dose to ensure treatment effect over their entire active day. CTx-1301 is designed to release dexmethylphenidate multiple times throughout the day in just one tablet, with the last release happening around the time that plasma concentrations of other stimulants start to wane,' said
CTx-1301 demonstrated a favorable safety profile in the trial compared to placebo. No patients reported experiencing insomnia during the randomized period.
'Along with a restricted duration of efficacy, another limitation of current stimulant-based treatments for ADHD is the phenomena of crash and rebound they produce. This can result in the recurrence or exaggeration of ADHD symptoms,' said
'To address this, we designed CTx-1301 to be a once-daily, rapid-onset tablet that is meant to provide entire active-day coverage along with a controlled descent in blood levels to mitigate the crash or rebound by avoiding the precipitous drop in blood levels usually associated with stimulants. We are encouraged by the Phase 3 data which should correlate with CTx-1301's onset and duration of action, thus improving ADHD symptoms from morning to night, all while offering a favorable safety profile.'
CTx-1301 is a novel, investigational treatment being developed as a true, once-daily stimulant medication for ADHD, upon approval from the
In addition to this Phase 3 adult dose-optimization study,
Detailed Results from Phase 3 Adult Safety and Efficacy Trial of CTx-1301 Demonstrate Improvements in ADHD Symptoms with Optimal Onset and Duration
Subjects who were randomized to their optimized dose of CTx-1301 showed improvements on the PERMP scores (effect size 0.88 to 2.60; average of 1.79) compared to subjects randomized to placebo, with a trend towards statistical significance for PERMP ratings over the 16-hour period (p=0.089). The treatment effect size of CTx-1301 was 1.41 at 30 minutes and 0.98 at 16 hours, which corresponded to onset and duration of effect. For comparison, a meta-analysis using 11 published studies of long-acting stimulants in adults found the average effect size to be 0.73 (approximately ranging from 0.5 to 0.9)1.
A key secondary endpoint of the trial was a change in CGI-S scores from baseline (pre-dose) at Visit 2 to Visit 8. CGI-S scores showed significant improvements in severity of illness in patients taking CTx-1301 (-1.2) compared to placebo (0.0), (p
(C) 2023 Electronic News Publishing, source