13 completed. 7 Phase 3, 3 Phase 2, 2 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 7 |
| Phase 2 | 3 | Completed 3 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 1 | Completed 1 |
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 |
|---|---|---|---|---|---|---|
| Irritation and Sensitization Study of d-Amphetamine Transdermal System dATS - Cumulative Irritation and Sensitization | Phase 1 | Completed | Noven Therapeutics | 229 | 2019-12-02 | 2020-08-24 |
| Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women Brisdelle (paroxetine mesylate) - Postmenopausal Symptoms | Phase 1 | Completed | Noven Therapeutics | 24 | 2011-07-01 | 2015-10-15 |
| Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS) Brisdelle (paroxetine mesylate), Placebo capsules - Postmenopausal Symptoms | Phase 3 | Completed | Noven Therapeutics | 614 | 2011-05-01 | 2015-10-15 |
| 24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Brisdelle (paroxetine mesylate), Placebo capsules - Hot Flashes | Phase 3 | Completed | Noven Therapeutics | 570 | 2010-03-01 | 2015-10-15 |
| Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause Brisdelle (paroxetine mesylate), Sugar pill - Hot Flashes | Phase 2 | Completed | Noven Therapeutics | 102 | 2008-11-01 | 2015-10-15 |
| Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD Methylphenidate Transdermal System - ADHD | Phase 3 | Completed | Noven Therapeutics | 163 | 2007-08-01 | 2017-04-26 |
| Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD methylphenidate transdermal system, Placebo - ADHD | Phase 3 | Completed | Noven Therapeutics | 217 | 2007-07-01 | 2017-04-26 |
| Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA Daytrana - Attention Deficit Hyperactivity Disorder | Phase 4 | Completed | Noven Therapeutics | 309 | 2007-01-01 | 2017-04-26 |
| Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy Methylphenidate Transdermal System - Attention Deficit Disorder With Hyperactivity | Phase 3 | Completed | Noven Therapeutics | 175 | 2005-06-01 | 2015-07-09 |
| Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD Methylphenidate Transdermal System, Placebo, Concerta - Attention Deficit Disorder With Hyperactivity | Phase 2 | Completed | Noven Therapeutics | 128 | 2005-06-01 | 2015-07-09 |
| Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials Methylphenidate Transdermal System - Attention Deficit Disorder With Hyperactivity | Phase 3 | Completed | Noven Therapeutics | 450 | 2004-10-01 | 2017-03-28 |
| Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD Methylphenidate Transdermal System, Placebo, Concerta - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Noven Therapeutics | 282 | 2004-09-01 | 2015-06-25 |
| Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD Methylphenidate Transdermal System - Attention Deficit Disorder With Hyperactivity | Phase 2 | Completed | Noven Therapeutics | 93 | 2004-08-01 | 2015-06-25 |
Attention Deficit Disorder with Hyperactivity (8) · Hot Flashes (3)
Methylphenidate (5) · Paroxetine (4) · Sugars (3)
United States (10)
Robin Kroll, MD (3) · Arthur Waldbaum, MD (2) · Ashley Tunkle, MD (2) · Cynthia Strout, MD (2) · D. S. Harnsberger, MD (2) · David J Portman, MD (2) · Derrick R Havin, MD (2) · Donna DeSantis, MD (2) · Eric Ross, MD (2) · John A. Hoekstra, MD (2) · Marvin Kalafer, MD (2) · Mildred Farmer, MD (2) · Peter A. Zedler, MD (2) · Richard E. Hedrick, MD (2) · Sandra Hurtado, MD (2)
PMID 24045678, PMID 24552977, PMID 25137243, PMID 16481664, PMID 18312050, PMID 19849639, PMID 19916704, PMID 20003260, PMID 20625364, PMID 20973706, PMID 20973707, PMID 21494336, PMID 23795577