CTx-1301 for ADHD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of CTx-1301, a new potential drug for adults with ADHD. Conducted in a classroom-like setting, the trial evaluates how well the medication manages ADHD symptoms in real-life situations. Researchers will assign participants to different groups to receive varying doses of the medication or a placebo, aiming to find the best dose for each person. The trial seeks adults dissatisfied with their current ADHD treatment or those diagnosed with ADHD but not currently taking medication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for ADHD.

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.

Is there any evidence suggesting that CTx-1301 is likely to be safe for humans?

Research has shown that CTx-1301, a medication being tested for ADHD, has promising safety results. In earlier studies, participants reported no serious side effects related to the treatment. Most handled the medication well, experiencing only minor side effects that were neither severe nor harmful. Additionally, CTx-1301 contains dexmethylphenidate, a stimulant commonly used to treat ADHD, which has a known safety record in similar medications. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ADHD?

CTx-1301 is unique because it delivers dexmethylphenidate, a well-known medication for ADHD, but aims to optimize its effectiveness and reduce side effects through precise dosing. Unlike some current ADHD treatments that can take time to adjust to the right dose, CTx-1301 uses a dose-optimization phase to quickly find the best dose for each individual, potentially improving symptom control. Additionally, the treatment is designed to maintain effectiveness throughout the day, which could offer better management of ADHD symptoms compared to existing options that may require multiple doses. Researchers are excited because this approach could lead to more personalized and consistent treatment for ADHD.

What evidence suggests that CTx-1301 might be an effective treatment for ADHD?

Research shows that CTx-1301 has promising results for treating ADHD symptoms. In this trial, participants will be titrated to their optimal dose of CTx-1301, which could be 25mg, 37.5mg, or 50mg, or they may receive a placebo. Studies have found that higher doses of this medication lead to better symptom control. In earlier research, CTx-1301 significantly improved ADHD symptoms, with noticeable effects within five hours of administration. The treatment has been effective for both children and teenagers, and it is expected to work similarly for adults. These findings suggest that CTx-1301 could be a strong option for managing ADHD symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Ann Childress, MD

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

Inclusion Criteria

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

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• CTx-1301

How Is the Trial Designed?

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+

Citations

1. cingulate.com cingulate.com/news-releases/news-release-details/cingulate-presents-positive-phase-3-results-ctx-1301

Cingulate Presents Positive Phase 3 Results for CTx-1301 ... “In summary, CTx1301 demonstrated dose dependent efficacy in improving ADHD symptoms in children and adolescents. The 37.5mg dose demonstrated ...

2. psychiatrictimes.com psychiatrictimes.com/view/positive-phase-3-results-ctx-1301-for-the-treatment-of-pediatric-adhd

Positive Phase 3 Results: CTx-1301 for the Treatment of ... CTx-1301 demonstrated significant dose-dependent efficacy in improving ADHD symptoms in children and adolescents, with rapid onset and sustained ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05631626

Phase 3 Efficacy and Safety Study in Adults With ADHD ... 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.

4. cingulate.com cingulate.com/news-releases/news-release-details/efficacy-results-announced-cingulates-phase-3-pediatric-study

Efficacy Results Announced from Cingulate's Phase 3 ... CTx-1301 demonstrated statistically significant improvements in ADHD symptoms across all fixed doses, achieving robust effect sizes (0.737 to 1.185) within 5 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05924594

Phase 3 Efficacy and Safety Laboratory Classroom Study ... 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. Detailed ...

6. cingulate.com cingulate.com/news-releases/news-release-details/cingulate-reports-safety-results-final-phase-3-trials-lead-adhd

Cingulate Reports Safety Results from Final Phase 3 Trials ... Mar 04, 2025 Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025.

7. contemporarypediatrics.com contemporarypediatrics.com/view/cingulate-reports-phase-3-safety-data-for-ctx-1301-to-treat-adhd-in-children-adolescents

Cingulate reports phase 3 safety data for CTx-1301 to treat ... Cingulate Inc. (NASDAQ: CING) has released Phase 3 safety data for CTx-1301 (dexmethylphenidate), a once-daily stimulant medication designed to provide full- ...

8. empr.com empr.com/news/novel-dexmethylphenidate-formulation-under-review-for-adhd/

Novel Dexmethylphenidate Formulation Under Review for ... As for safety, no serious treatment-emergent adverse events were reported across all studies. The tolerability profile was also similar to that ...

9. chadd.org chadd.org/adhd-in-the-news/cingulate-reports-phase-3-safety-data-for-ctx-1301-to-treat-adhd-in-children-adolescents/

Cingulate reports phase 3 safety data for CTx-1301 to treat ... Cingulate Inc. (NASDAQ: CING) has released Phase 3 safety data for CTx-1301 (dexmethylphenidate), a once-daily stimulant medication designed ...