Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301
Public ClinicalTrials.gov record NCT05286762. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Double-blind, Randomized, Placebo-controlled, Multi-center, Fixed-dose, Parallel Group Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)
Study identification
- NCT ID
- NCT05286762
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Cingulate Therapeutics
- Industry
- Enrollment
- 103 participants
Conditions and interventions
Conditions
Interventions
- CTx-1301-Dexmethylphenidate 12.5 mg (titration only) Drug
- 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) Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2023
- Primary completion
- Feb 28, 2024
- Completion
- Feb 28, 2024
- Last update posted
- Jan 21, 2026
2023 – 2024
United States locations
- U.S. sites
- 24
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| Meridien Research | Maitland | Florida | 32751 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Sisu Bhr, Llc | Springfield | Massachusetts | 01103 | — |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | — |
| St Charles Psychiatric Associates & Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Center for Psychiatry and Behavioral Medicine. Inc. | Las Vegas | Nevada | 89128 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Dayton Clinical Research | Dayton | Ohio | 45409 | — |
| SP Research PLLC | Oklahoma City | Oklahoma | 73112 | — |
| Summit Research Network, LLC | Portland | Oregon | 97210 | — |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Access Clinical Trials Inc. | Nashville | Tennessee | 37203 | — |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | — |
| Gadolin Research | Beaumont | Texas | 77702 | — |
| Houston Clinical Trials | Bellaire | Texas | 77401 | — |
| FutureSearch Trials | Dallas | Texas | 75231 | — |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | — |
| Family Psychiatry of The Woodlands | Woodland | Texas | 77381 | — |
| Clinical Research Partners LLC | Petersburg | Virginia | 23805 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05286762, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2026 · Synced May 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05286762 live on ClinicalTrials.gov.