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Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.

A Phase 3, Dose-Optimized, Randomized, Double-Blind, Placebo-Controlled, Single-Center, Parallel Efficacy and Safety Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

NCT05631626•Cingulate Therapeutics

View on ClinicalTrials.gov

Summary

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

Detailed Description

A single-center, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy and safety laboratory classroom study with CTx-1301 in approximately 25 adults aged 18 to 55 years with ADHD. The study will be comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a safety follow-up phase. Subjects will undergo a screening visit prior to entering a 5-week dose-optimization phase. During the dose-optimization phase subjects will have weekly visit and will be titrated to doses ranging between 25mg-50mg of CTx-1301. Eligible subjects will be randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice Adult Laboratory Classroom (ALC) visit with 4 PERMP assessments. Subjects will take their assigned/randomized dose over the following 7-day period. On the 7th day subjects will complete a full ALC visit. The duration of the full ALC visit will be approximately 17 hours. Subjects will have an in-clinic safety follow-up visit within 7 days after the full adult laboratory classroom visit.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female subjects between 18 and 55 years of age (inclusive) at the time of consent.
•2. Subject must have a body mass index (BMI) ≥18.5 and ≤40.
•3. Subject is unsatisfied with his/her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects who are naïve to pharmacological therapy for ADHD is permitted.
•4. Negative serum beta-human chorionic gonadotropin (hCG) pregnancy test for subjects of child-bearing potential and must agree to remain abstinent or agree to use a highly effective, medically acceptable form of birth control for the time of written or verbal consent and for at least 30 days after the last dose of study drug has been taken (females) unless post-menopausal or surgically sterile. Male subjects with female partners must agree at Screening to remain abstinent or agree to use an effective and medically acceptable form of birth control from Screening to 90 days after the last dose of study drug.

Exclusion Criteria

•6. Subject's intellectual function is at an appropriate level, as deemed by the Investigator.
•7. Subjects need to be able to perform at least the basic level of problems on the PERMP pre-test with at least 10 questions answered correctly per page or 2 minutes performed at Visit 2.
•8. Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for the primary diagnosis of ADHD for any of the three presentations (combined, inattentive, or hyperactive/impulsive presentation) upon clinical evaluation and confirmed by the Mini International Neuropsychiatric Interview for Attention Deficit/Hyperactivity Disorder - Adults (MINI).
•9. Subject must score 24 or higher on the Adult ADHD Investigator Rating Scale (AISRS) at the Screening visit (Visit 1) and Baseline visit (Visit 2) if no ADHD medication washout is required. For subjects requiring washout of ADHD medications, this criterion refers to a score following washout at the Baseline visit (Visit 2).
•10. Subject must have a score of 4 (moderately ill) or higher on the clinician-administrated Clinical Global Impressions-Severity (CGI-S) scale at Screening. For subjects requiring washout of ADHD medications, this criterion refers to a score at the Baseline visit (Visit 2).
•11. Subject must be able and willing to wash out of all stimulant ADHD medications (except study drug as indicated per protocol), including herbal medication, from 5 days prior to the start of the dose-optimization phase and for the duration of the entire study, defined as completion of the safety follow-up visit. Additionally, subject must be able and willing to wash out from all non-stimulant ADHD medications 21 days prior to the start of the dose optimization phase and for the duration of the entire study, defined as completion of the safety follow-up visit.
•12. Subject must be able to read, write, speak, and understand English and be able to communicate with the Investigator and study coordinator in a satisfactory fashion and complete any study-related materials. Subject must plan to be available for the entire duration of the study.
•1. If female and of child-bearing potential, the subject must not be pregnant or breastfeeding at any time during the study or for 30 days following the completion of the study. If of child-bearing potential, urine hCG tests will be administered at protocol specified time points. Any positive pregnancy test during the study will exclude them from further participation in the study.
•2. Subject has any psychiatric diagnosis of bipolar I or II disorder, current major depressive disorder, conduct disorder, disruptive mood dysregulation disorder, intellectual disability, obsessive-compulsive disorder, eating disorder, anxiety disorder (including generalized anxiety disorder), any history of psychosis, autism spectrum disorder, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances, or any other diagnosis/significant medical history that at the discretion of the Investigator excludes the subject from entry into the study.
•3. Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS-related disorders that might occur in childhood, or history of persistent neurological symptoms related to a serious head injury.
+25 more criteria

Locations (1)

Clinical Research of Southern Nevada, LLC

Las Vegas, Nevada, United States

Key Dates

Start Date

December 29, 2022

Primary Completion Date

June 13, 2023

Completion Date

June 13, 2023

Last Updated

August 14, 2025

Enrollment

ACTUAL participants

Conditions

ADHDADHD - Combined TypeAttention Deficit Hyperactivity Disorder CombinedAttention Deficit Hyperactivity Disorder

Interventions

CTx-1301 - Dexmethylphenidate 25mg

DRUG

CTx-1301 - Dexmethylphenidate 37.5mg

DRUG

CTx-1301 - Dexmethylphenidate 50mg

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.

Inclusion Criteria

Exclusion Criteria

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