Cingulate has completed the Phase III trial of its lead candidate CTx-1301 (dexmethylphenidate) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults.
The parallel efficacy and safety, placebo-controlled, double-blind, dose-optimised, single-centre, randomised study has evaluated the onset and duration of CTx-1301 in an adult laboratory classroom (ALC) setting.
A total of 21 adults aged 18-55 years with ADHD were enrolled and administered with a once-daily stimulant medication of CTx-1301.
Subjects were screened and randomised into a 1:1 ratio to receive either placebo or an optimal dose between 25 mg and 50 mg, determined during a five-week dose-optimisation phase.
The study also includes a double-blind randomised phase followed by a seven-day safety follow-up period.
Evaluating CTx-1301’s efficacy against placebo in treating ADHD adults in an ALC study was the primary objective while determining the onset and duration of the candidate was included as the secondary objective.
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Determining the tolerability and safety of CTx-1301 against placebo was also a part of the study’s secondary objectives.
Results from the trial are anticipated in the third quarter of this year.
Furthermore, the study assessed the quality and satisfaction of earlier medications to CTx-1301.
Cingulate chief science officer Raul Silva said: “If the Phase III CTx-1301-022 study results are positive, these data will add to the growing body of evidence from earlier trials showing that CTx-1301 has the potential to offer patients best-in-class onset and duration.”
Cingulate is planning to submit CTx-1301’s new drug application (NDA) in the US in the middle of next year, under the Section 505(b)(2) pathway.
It is also set to commence its Phase III fixed-dose paediatric and adolescent study and dose-optimisation onset and duration trial in paediatric patients in the third quarter of this year.