Clinical Trials
6
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
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Clinical Trials
Distribution across different clinical trial phases (6 trials with phase data)• Click on a phase to view related trials
In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted)
- Conditions
- Healthy Volunteers in Fed and Fasted State
- Interventions
- First Posted Date
- 2025-08-12
- Last Posted Date
- 2025-08-12
- Lead Sponsor
- Cingulate Therapeutics
- Target Recruit Count
- 25
- Registration Number
- NCT07119073
- Locations
- 🇺🇸
Dr. Vince Clinical Research, Overland Park, Kansas, United States
Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301
- Conditions
- Attention Deficit Hyperactivity DisorderAttention-deficit HyperactivityADHDADHD - Combined TypeAttention Deficit Disorder With HyperactivityAttention Deficit Hyperactivity Disorder CombinedAttention Deficit Hyper Activity
- Interventions
- First Posted Date
- 2023-06-29
- Last Posted Date
- 2025-08-14
- Lead Sponsor
- Cingulate Therapeutics
- Target Recruit Count
- 45
- Registration Number
- NCT05924594
- Locations
- 🇺🇸
Accel Research Sites, Maitland, Florida, United States
🇺🇸Center for Psychiatry & Behavioral Medicine, Las Vegas, Nevada, United States
🇺🇸Coastal Carolina Research Center, North Charleston, South Carolina, United States
Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.
- Conditions
- Attention Deficit Hyperactivity DisorderADHDADHD - Combined TypeAttention Deficit Hyperactivity Disorder Combined
- Interventions
- First Posted Date
- 2022-11-30
- Last Posted Date
- 2025-08-14
- Lead Sponsor
- Cingulate Therapeutics
- Target Recruit Count
- 21
- Registration Number
- NCT05631626
- Locations
- 🇺🇸
Clinical Research of Southern Nevada, LLC, Las Vegas, Nevada, United States
Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301
- Conditions
- ADHDAttention Deficit Hyperactivity DisorderAttention-deficit HyperactivityAttention Deficit Hyper ActivityADHD - Combined TypeAttention Deficit Hyperactivity Disorder Combined
- Interventions
- Drug: CTx-1301-Dexmethylphenidate 12.5 mg (titration only)Drug: PlaceboDrug: CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose)Drug: CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose)Drug: CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose)
- First Posted Date
- 2022-03-18
- Last Posted Date
- 2025-08-15
- Lead Sponsor
- Cingulate Therapeutics
- Target Recruit Count
- 103
- Registration Number
- NCT05286762
- Locations
- 🇺🇸
Clinical Neuroscience Solutions, Inc., Memphis, Tennessee, United States
🇺🇸Meridien Research, Maitland, Florida, United States
🇺🇸Atlanta Center for Medical Research, Atlanta, Georgia, United States
Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects
- Conditions
- Healthy Volunteers in Fed and Fasted State
- Interventions
- First Posted Date
- 2020-06-26
- Last Posted Date
- 2022-10-20
- Lead Sponsor
- Cingulate Therapeutics
- Target Recruit Count
- 27
- Registration Number
- NCT04449250
- Locations
- 🇺🇸
Dr. Vince Clinical Research, Overland Park, Kansas, United States
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News
Cingulate Advances CTx-1301 for ADHD Treatment with Positive Phase III Safety Data and Upcoming FDA Pre-NDA Meeting
Cingulate Inc. has completed its fast-fed study and submitted safety data from Phase III trials for CTx-1301, its ADHD treatment candidate, with no serious adverse events reported in pediatric and adolescent studies.