CTx-1301 Demonstrates Improvements in ADHD Across 3 Dosages
Patients included in the study were aged 6 to 17 years with attention deficit/hyperactivity disorder (ADHD).
CTx-1301 (dexmethylphenidate HCl) demonstrated improvements in attention deficit/hyperactivity disorder (ADHD) across the 18.75 mg, 25 mg, and 37.5 mg dosages in the CTx-1301-005 (NCT05286762) study.1
Patients included in the study were aged 6 to 17 years with attention deficit/hyperactivity disorder (ADHD). | Image Credit: ClareM - stock.adobe.com
"In a randomized, double-blind, placebo-controlled phase 3 trial in pediatric ADHD patients, CTx-1301 demonstrated statistically significant improvements in ADHD symptoms across all fixed doses, achieving robust effect sizes (0.737 to 1.185) within 5 weeks,” Raul R. Silva, MD, chief science officer at Cingulate, said in a news release.1 “These results illustrate that CTx-1301, if approved by the FDA, is positioned to become a potential first-line treatment for providers to overcome the longstanding unmet needs facing the millions of ADHD patients worldwide.”
The study was comprised of a screening period, double-blind randomized phase, and safety follow-up, according to the clinical trial information. Patients included in the study were aged 6 to 17 years with ADHD confirmed by an ADHD Rating Scale 5 (ADHD-RS-5) score of at least 28. Patients also had a Clinical Global Impression-Severity (CGI-S) score of at least 4 at screening, correlating to being “moderately ill.”2
In the screening period, patients underwent a screening visit up to 30 days prior to randomized treatment. Patients who met all inclusion criteria were considered for entry, and there was a reminder phone call to all patients prior to day 0 (visit 2), according to the clinical trial information. In the randomized treatment period, individuals received one of the 3 fixed doses or the placebo. Patients given active treatment started on 12.5 mg dosages until they reached their assigned fixed dose and must reach their fixed dose a minimum of 2 weeks prior to the primary efficacy assessment at week 5. In the safety follow-up on day 42, patients were evaluated for washout of medication.2
The primary outcome was the analysis of mean change from baseline to week 5 in the ADHD-RS-5. The secondary outcome included the change from baseline to week 5 in CGI-S scores. Safety outcomes included the incidence of treatment-related adverse events (AEs), incidence of changes in vital signs, incidence of changes in blood labs, incidence of changes in physical exams, incidence of changes in body mass index, incidence of changes in Columbia-Suicide Severity Rating Scale, and incidence of changes in electrocardiogram.2
“These compelling results once again validate the therapeutic benefits and commercial potential of CTx-1301. Achieving statistically significant outcomes and remarkable effect sizes across all tested dose levels illustrates the potential benefits of our product and the value of our Precision Timed Release Platform,” Shane J. Schaffer, chairman and CEO of Cingulate, said in the news release.1
Previously, the company announced safety results for the drug. The data show that no individuals had serious treatment-emergent AEs or treatment-emergent AEs leading to death. Further, there were no clinically relevant trends for treatment-emergent AEs overall. Data also show that the drug can be taken with or without food.3
READ MORE: Mental and Behavioral Health Resource Center
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