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

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in children (6-12) with ADHD in a laboratory classroom setting.

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

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.

Sponsors & Collaborators

• Cingulate Therapeutics

  lead INDUSTRY

Principal Investigators

• Matt Brams, MD · Cingulate

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-31

Primary Completion

2027-02-28

Completion

2027-02-28

FDA Drug

Yes

Countries

• United States

Study Locations