CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 103 enrolled
Drug / intervention
CTx-1301-Dexmethylphenidate 12.5 mg (titration only) +4 moredrug
Likely dose
CTx-1301-Dexmethylphenidate 12.5 mg (titration only)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05286762
NCT05286762Phase 3Completed
CompareCT.gov

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multi-center, Fixed-dose, Parallel Group Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

Cingulate Therapeutics·interventional·Posted Mar 18, 2022·Updated Jan 22, 2026

In Brief

A Phase 3 clinical trial evaluating CTx-1301-Dexmethylphenidate 12.5 mg (titration only), CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose), and 3 other interventions for ADHD and 5 related conditions. Completed, enrolled 103 participants across 24 sites.

Detailed Summary

A Phase 3, randomized, double-blind, placebo-controlled, multi-center, fixed-dose, parallel-group efficacy and safety study in a pediatric population (6-17) with Attention-Deficit/Hyperactivity Disorder (ADHD) using CTx-1301 (d-MPH). The study will be comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD, Attention Deficit Hyperactivity Disorder, ADHD - Combined Type, Attention Deficit Hyperactivity Disorder Combined, Attention-deficit Hyperactivity, Attention Deficit Hyper Activity
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMar 18, 2022
Enrollment StartAug 1, 2023
Primary CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.3 years ago

Interventions

CTx-1301-Dexmethylphenidate 12.5 mg (titration only)drug

Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg

CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose)drug

Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg

CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose)drug

Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg

CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose)drug

Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg

Placebodrug

Subjects will be randomized at Visit 2 to Placebo