18 completed, 1 recruiting, 1 suspended. 7 Phase 4, 6 Phase 1, 4 Phase 3, 3 Phase 2, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 7 | Completed 6, Recruiting 1 |
| Phase 1 | 6 | Completed 6 |
| Phase 3 | 4 | Completed 3, Suspended 1 |
| Phase 2 | 3 | Completed 3 |
| Early Phase 1 | 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 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 |
| A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) - Attention Deficit/Hyperactivity Disorder | Phase 4 | Completed | Corium, Inc. | 123 | 2023-06-02 | 2026-05-08 |
| An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH), placebo - Attention Deficit/Hyperactivity Disorder | Phase 4 | Completed | Corium, Inc. | 246 | 2023-03-22 | 2025-05-13 |
| 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 |
| Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate - Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder | Completed | Nemours Children's Clinic | 70 | 2020-09-13 | 2022-12-13 | |
| 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 |
| Stimulant Effects on Disruptive Behavior Stimulant - Attention Deficit Hyperactivity Disorder, Problem Behavior | Phase 4 | Recruiting | Matthew J O'Brien, PhD, BCBA-D | 10 | 2018-10-01 | 2025-03-17 |
| Omega-3 Supplementation to ADHD Medication in Children Omega-3 Fatty Acid, ADHD Medication - Attention Deficit Hyperactivity Disorder, Deficient Emotional Self-Regulation | Phase 4 | Completed | Massachusetts General Hospital | 21 | 2014-07-01 | 2017-06-29 |
| Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study Methylphenidate, Modafinil, MDMA - Healthy, Substance-related Disorder | Early Phase 1 | Completed | University Hospital, Basel, Switzerland | 24 | 2013-10-01 | 2016-01-21 |
| Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits ADHD Medication, Omega-3 Fatty Acids - Attention Deficit Hyperactivity Disorder (ADHD), Deficient Emotional Self-Regulation (DESR) | Phase 2 | Completed | Massachusetts General Hospital | 2 | 2012-02-01 | 2018-10-23 |
| A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) Dex-methylphenidate hydrochloride extended-release (Focalin XR), Placebo - Attention Deficit Hyperactivity Disorder | Phase 4 | Completed | Novartis Pharmaceuticals | 86 | 2007-10-01 | 2012-04-27 |
| Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder Guanfacine, Methylphenidate (MPH) - Attention Deficit Disorder With Hyperactivity | Phase 4 | Completed | University of California, Los Angeles | 212 | 2007-01-01 | 2021-07-30 |
| Study of Dopamine Transporter Receptor Occupancy With Long-acting Dex-methylphenidate dex-methylphenidate - Drug Binding to DAT Receptors | Phase 1 / Phase 2 | Completed | Massachusetts General Hospital | 23 | 2006-12-01 | 2013-10-22 |
| Use of Focalin for Fatigue in Sarcoidosis d-methylphenidate - Sarcoidosis | Phase 4 | Completed | University of Cincinnati | 12 | 2006-06-01 | 2011-02-24 |
| Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR Dexmethylphenidate, Mixed Amphetamine Salts, ER, placebo - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Seattle Children's Hospital | 77 | 2006-01-01 | 2017-04-19 |
| Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD Focalin XR - ADHD | Phase 3 | Completed | Novartis | 90 | 2005-06-01 | 2007-12-21 |
| Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD Focalin XR - ADHD | Phase 3 | Completed | Novartis | 90 | 2005-05-01 | 2007-12-21 |
| Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions Dexmethylphenidate Hydrochloride - Healthy | Phase 1 | Completed | Teva Pharmaceuticals USA | 24 | 2004-06-01 | 2024-08-19 |
| Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions Dexmethylphenidate Hydrochloride - Healthy | Phase 1 | Completed | Teva Pharmaceuticals USA | 24 | 2004-06-01 | 2024-08-19 |
Attention Deficit Disorder with Hyperactivity (13) · Fasting (2) · Mood Disorders (1) · Problem Behavior (1) · Sarcoidosis (1) · Substance-Related Disorders (1)
Cingulate Therapeutics (4) · Massachusetts General Hospital (3) · Corium, Inc. (2) · Novartis (2) · Teva Pharmaceuticals USA (2) · Matthew J O'Brien, PhD, BCBA-D (1) · Nemours Children's Clinic (1) · Novartis Pharmaceuticals (1) · Seattle Children's Hospital (1) · University Hospital, Basel, Switzerland (1) · University of California, Los Angeles (1) · University of Cincinnati (1)
United States (19) · Switzerland (1)
Matt Brams, MD (4) · Ann Childress, MD (3) · Irwin Plisco, M.D. (2) · Craig Surman, MD (1) · Elizabeth Charney, MD (1) · James J. McGough, MD (1) · James T. McCracken, MD (1) · Kyoko Nagao, PhD (1) · Mark A Stein, PhD (1) · Matthew Brams, MD (1) · Matthew J O'Brien, PhD (1) · Matthias E Liechti, MD, MAS (1) · Robert P Baughman, MD (1) · Thomas Spencer, MD (1)
PMID 18263672, PMID 22136094, PMID 22154896, PMID 25056567, PMID 27453079, PMID 27453080, PMID 27453081, PMID 27483130, PMID 28551715, PMID 29912955, PMID 35963558, PMID 35963559, PMID 36913518, PMID 36971690, PMID 41342306, PMID 42518155
P50MH077248 (1)