NCT05924594View on ClinicalTrials.gov

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

PHASE3SuspendedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

July 31, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
ADHDADHD - Combined TypeAttention Deficit Hyper ActivityAttention Deficit Hyperactivity DisorderAttention Deficit Disorder With HyperactivityAttention Deficit Hyperactivity Disorder CombinedAttention-deficit Hyperactivity
Interventions
DRUG

CTx-1301 - Dexmethylphenidate 6.25mg

All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

DRUG

CTx-1301 - Dexmethylphenidate 12.5mg

All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

DRUG

CTx-1301 - Dexmethylphenidate 18.75mg

All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

DRUG

CTx-1301 - Dexmethylphenidate 25.0mg

All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

DRUG

CTx-1301 - Dexmethylphenidate 31.25mg

All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

DRUG

CTx-1301 - Dexmethylphenidate 37.5mg

All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

DRUG

Placebo

Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomized phase.

Trial Locations (3)

29405

Coastal Carolina Research Center, North Charleston

32751

Accel Research Sites, Maitland

89128

Center for Psychiatry & Behavioral Medicine, Las Vegas

Sponsors
All Listed Sponsors
lead

Cingulate Therapeutics

INDUSTRY

NCT05924594 - Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 | Biotech Hunter | Biotech Hunter