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

Overseen By Matt Brams, MD Study Director

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Cingulate Therapeutics

Must not be taking: Anticonvulsants

Disqualifiers: Bipolar, Major depression, Anxiety, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests CTx-1301, a medication for adults with ADHD, by finding the best dose. The goal is to see if CTx-1301 can effectively manage ADHD symptoms.

Will I have to stop taking my current medications?

Yes, you will need to stop taking all stimulant ADHD medications 5 days before starting the trial and all non-stimulant ADHD medications 21 days before starting. This is required for the entire duration of the study.

Research Team

Ann Childress, MD

Principal Investigator

Principal Investigator

Eligibility Criteria

Inclusion Criteria

Subject must have a body mass index (BMI) ≥18.5 and ≤40.

Male or female subjects between 18 and 55 years of age (inclusive) at the time of consent.

Subject must be in general good health defined as absence of any clinically relevant abnormalities as determined by the Investigator based on physical and neurological examinations, vital signs, ECGs, medical history, and laboratory values (hematology, chemistry, or urinalysis) at Screening. If any of the exams or values are not within the laboratory reference range, the Investigator must review range and determine if clinically relevant. If clinically relevant, the subject is not eligible for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Dose-Optimization

Participants undergo dose titration to find their optimal dose of CTx-1301, with weekly visits for dose adjustments

5 weeks

5 visits (in-person)

Double-Blind Randomization

Participants are randomized to receive either their optimal dose of CTx-1301 or placebo for a 7-day period, culminating in a full Adult Laboratory Classroom visit

1 week

1 visit (in-person, 17 hours)

Safety Follow-up

Participants have an in-clinic safety follow-up visit to monitor for any adverse events

1 week

1 visit (in-person)

Treatment Details

Interventions

• CTx-1301

Participant Groups

Group I: 50mg CTx-1301 (Dexmethylphenidate tablet) Active Control 1 Intervention

All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.

Group II: 37.5mg CTx-1301 (Dexmethylphenidate tablet) Active Control 1 Intervention

All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.

Group III: 25mg CTx-1301 (Dexmethylphenidate tablet) Active Control 1 Intervention

All subjects will be titrated to their optimal dose during the dose-optimization phase. The starting dose for all subjects at Day 0 is 25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.

Group IV: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Cingulate Therapeutics

Lead Sponsor

Trials

5

Recruited

240+

Rho, Inc.

Industry Sponsor

Trials

25

Recruited

5,800+