5 completed, 1 suspended. 3 Phase 1, 3 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 3 | Completed 2, Suspended 1 |
| Phase 2 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted) Dexmethylphenidate - Healthy Volunteers in Fed and Fasted State | Phase 1 | Completed | Cingulate Therapeutics | 25 | 2024-10-31 | 2025-08-12 |
| Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 CTx-1301-Dexmethylphenidate 12.5 mg (titration only), CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose), CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose) - ADHD, Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Cingulate Therapeutics | 103 | 2023-08-01 | 2026-01-22 |
| Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 CTx-1301 - Dexmethylphenidate 6.25mg, CTx-1301 - Dexmethylphenidate 12.5mg, CTx-1301 - Dexmethylphenidate 18.75mg - ADHD, ADHD - Combined Type | Phase 3 | Suspended | Cingulate Therapeutics | 45 | 2023-07-31 | 2026-05-05 |
| Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. CTx-1301 - Dexmethylphenidate 25mg, CTx-1301 - Dexmethylphenidate 37.5mg, CTx-1301 - Dexmethylphenidate 50mg - ADHD, ADHD - Combined Type | Phase 3 | Completed | Cingulate Therapeutics | 26 | 2022-12-29 | 2026-07-02 |
| Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects Dexmethylphenidate - Healthy Volunteers in Fed and Fasted State | Phase 1 | Completed | Cingulate Therapeutics | 27 | 2022-09-14 | 2022-10-20 |
| CTx-1301 Comparative Bioavailability Study Dexmethylphenidate 5 Mg Oral Capsule, Extended Release, Dexmethylphenidate 6.25 mg Tablet, Dexmethylphenidate 40 Mg Oral Capsule, Extended Release - ADHD | Phase 1 / Phase 2 | Completed | Cingulate Therapeutics | 45 | 2019-12-06 | 2021-04-08 |
Attention Deficit Disorder with Hyperactivity (4) · Fasting (2)
Dexmethylphenidate Hydrochloride (4) · Capsules (1) · Double-Blind Method (1) · Random Allocation (1) · Tablets (1)
United States (6)
Matt Brams, MD (5) · Ann Childress, MD (2)