9 completed. 6 Phase 1, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 6 |
| Phase 4 | 3 | Completed 3 |
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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 |
|---|---|---|---|---|---|---|
| Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening Serdexmethylphenidate/dexmethylphenidate - Adult Attention Deficit Hyperactivity Disorder | Phase 4 | Completed | NYU Langone Health | 29 | 2023-11-13 | 2025-07-29 |
| 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 |
| Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers Donepezil TDS, Aricept - Healthy Subjects | Phase 1 | Completed | Corium, Inc. | 60 | 2020-12-08 | 2024-09-19 |
| A Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil Transdermal Delivery System (TDS) Donepezil TDS - Alzheimer's Disease | Phase 1 | Completed | Corium, Inc. | 24 | 2018-02-13 | 2018-09-14 |
| A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations Donepezil TDS - Alzheimer's Disease | Phase 1 | Completed | Corium, Inc. | 66 | 2018-01-31 | 2018-08-07 |
| A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System Donepezil TDS, Vehicle TDS - Skin Irritation, Sensitization | Phase 1 | Completed | Corium, Inc. | 256 | 2017-11-14 | 2018-09-14 |
| A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept® Donepezil TDS, Aricept - Alzheimer's Disease | Phase 1 | Completed | Corium, Inc. | 86 | 2017-10-30 | 2018-08-01 |
| A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept® Donepezil TDS Version A, Donepezil TDS Version B, Aricept - Alzheimer Disease | Phase 1 | Completed | Corium, Inc. | 107 | 2016-11-01 | 2018-08-01 |
Alzheimer Disease (4) · Attention Deficit Disorder with Hyperactivity (3)
Donepezil (3) · Dexmethylphenidate Hydrochloride (2) · serdexmethylphenidate and dexmethylphenidate (1)
United States (9)
Danielle Armas, MD (3) · Ann Childress, MD (2) · Danielle Armas (1) · Danielle Armas, MD, CPI (1) · Laura Sterling, MD, MPH (1) · Lenard Adler (1) · Robert Bass, MD (1) · Vaeling Miller (1)