Biopharmaceutical company Cingulate has completed the first cohort of its Phase III adult onset and duration trial of CTx-1301 (dexmethylphenidate) to treat attention deficit/hyperactivity disorder (ADHD).
The randomised, dose-optimised, single-centre, double-blind, placebo-controlled parallel efficacy and safety adult laboratory classroom (ALC) Phase III CTx-1301-022 trial was designed to evaluate the onset and duration of CTx-1301 in up to 25 ADHD adult patients aged between 18 and 55 years in an ALC setting.
It includes a screening period, a five-week dose-optimisation phase, a double-blind randomised phase, and a safety follow-up period of seven days.
In the trial, participants will undergo a screening visit before entering a five-week dose-optimisation phase.
They will have weekly visits and will receive CTx-1301 doses ranging between 25mg and 50mg, during the dose-optimisation phase of the trial.
The investigation of CTx-1301’s efficacy compared to placebo in ADHD adults is the trial’s primary objective.
The determination of CTx-1301’s tolerability and safety compared to placebo, as well as the onset and duration of clinical effect of CTx-1301 in treating ADHD adults are some of the secondary objectives of the trial.
Satisfaction and quality of prior medication to CTx-1301 will also be assessed in the trial.
Cingulate chairman and CEO Shane Schaffer said: “We’re pleased with the speed in which our first cohort of this Phase III trial was able to be completed, underscoring the ADHD community’s interest in new stimulant treatment options and affirming our goal of having full trial results by third quarter 2023.
“There is a large and growing population of adults with ADHD who with appropriate diagnosis stand to benefit from effective entire active-day efficacy, and we’re confident that an optimised version of the already-established active ingredient in CTx-1301, dexmethylphenidate, could be an important addition to the $22bn ADHD market.”
The company also intends to start its pivotal Phase III fixed-dose paediatric and adolescent study in the middle of this year.