Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.
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
Timeline
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
Treatment Details
Interventions
- CTx-1301
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cingulate Therapeutics
Lead Sponsor
Rho, Inc.
Industry Sponsor