Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301
Public ClinicalTrials.gov record NCT05924594. 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, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy and Safety Laboratory Classroom Study in Children (6-12) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)
Study identification
- NCT ID
- NCT05924594
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Cingulate Therapeutics
- Industry
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Interventions
- CTx-1301 - Dexmethylphenidate 12.5mg Drug
- CTx-1301 - Dexmethylphenidate 18.75mg Drug
- CTx-1301 - Dexmethylphenidate 25.0mg Drug
- CTx-1301 - Dexmethylphenidate 31.25mg Drug
- CTx-1301 - Dexmethylphenidate 37.5mg Drug
- CTx-1301 - Dexmethylphenidate 6.25mg Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 12 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 30, 2023
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2027
- Last update posted
- May 4, 2026
2023 – 2027
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Accel Research Sites | Maitland | Florida | 32751 | — |
| Center for Psychiatry & Behavioral Medicine | Las Vegas | Nevada | 89128 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
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 NCT05924594, 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 May 4, 2026 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05924594 live on ClinicalTrials.gov.