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ClinicalTrials.gov public records Last synced Sep 17, 2026, 4:48 AM EDT

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Showing 1–2 of 2 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: CTx-1301 - Dexmethylphenidate 12.5mg Clear all
Completed Phase 3 Interventional Results available

Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301

NCT05286762
View directory record Official record
Conditions
ADHD, Attention Deficit Hyperactivity Disorder, ADHD - Combined Type, Attention Deficit Hyperactivity Disorder Combined, Attention-deficit Hyperactivity, Attention Deficit Hyper Activity
Interventions
CTx-1301-Dexmethylphenidate 12.5 mg (titration only), CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose), CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose), CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose), Placebo
Drug
Lead sponsor
Cingulate Therapeutics
Industry
Eligibility
6 Years to 17 Years
Enrollment
103 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
24
States / cities
Jacksonville, Florida • Maitland, Florida • Orlando, Florida + 21 more
Source: ClinicalTrials.gov public record
Updated Jan 21, 2026 · Synced Sep 17, 2026, 4:48 AM EDT
Suspended Phase 3 Interventional

Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301

NCT05924594
View directory record Official record
Conditions
ADHD, ADHD - Combined Type, Attention Deficit Hyper Activity, Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder With Hyperactivity, Attention Deficit Hyperactivity Disorder Combined, Attention-deficit Hyperactivity
Interventions
CTx-1301 - Dexmethylphenidate 6.25mg, CTx-1301 - Dexmethylphenidate 12.5mg, CTx-1301 - Dexmethylphenidate 18.75mg, CTx-1301 - Dexmethylphenidate 25.0mg, CTx-1301 - Dexmethylphenidate 31.25mg, CTx-1301 - Dexmethylphenidate 37.5mg, Placebo
Drug
Lead sponsor
Cingulate Therapeutics
Industry
Eligibility
6 Years to 12 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
3
States / cities
Maitland, Florida • Las Vegas, Nevada • North Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated May 4, 2026 · Synced Sep 17, 2026, 4:48 AM EDT