CTx-1301 for ADHD
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.12345
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.26789
Who Is on the Research Team?
Ann Childress, MD
Principal Investigator
Principal Investigator
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-Optimization
Participants undergo dose titration to find their optimal dose of CTx-1301, with weekly visits for dose adjustments
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
Safety Follow-up
Participants have an in-clinic safety follow-up visit to monitor for any adverse events
What Are the Treatments Tested in This Trial?
Interventions
- CTx-1301
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
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.
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.
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.
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cingulate Therapeutics
Lead Sponsor
Rho, Inc.
Industry Sponsor
Citations
1.
cingulate.com
cingulate.com/news-releases/news-release-details/cingulate-presents-positive-phase-3-results-ctx-1301Cingulate 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-adhdPositive 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 ...
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-studyEfficacy 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 ...
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-adhdCingulate 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-adolescentsCingulate 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- ...
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 ...
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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.