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

NCT05286762 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-01-22

Study results available
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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.

Conditions

  • ADHD - Combined Type
  • ADHD
  • Attention Deficit Hyperactivity Disorder
  • Attention Deficit Hyperactivity Disorder Combined
  • Attention-deficit Hyperactivity
  • Attention Deficit Hyper Activity

Interventions

DRUG

CTx-1301-Dexmethylphenidate 12.5 mg (titration only)

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

DRUG

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

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

DRUG

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

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

DRUG

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

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

DRUG

Placebo

Subjects will be randomized at Visit 2 to Placebo

Sponsors & Collaborators

  • Cingulate Therapeutics

    lead INDUSTRY

Principal Investigators

  • Matt Brams, MD · Cingulate

  • Ann Childress, MD · Center for Psychiatry And Behavioral Medicine Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-02-29
Completion
2024-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286762 on ClinicalTrials.gov