13 completed, 3 terminated, 1 recruiting. 5 Phase 2, 4 Phase 1, 4 Phase 3, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 3, Recruiting 1, Terminated 1 |
| Phase 1 | 4 | Completed 3, Terminated 1 |
| Phase 3 | 4 | Completed 3, Terminated 1 |
| 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 |
|---|---|---|---|---|---|---|
| Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users Placebo, Oxycodone 20 mg, GE-IR 200 mg - Abuse Potential | Phase 4 | Completed | Arbor Pharmaceuticals, Inc. | 110 | 2022-01-31 | 2024-08-12 |
| An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users Placebo, Alprazolam 2 mg, Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg - Abuse Potential | Phase 4 | Completed | Arbor Pharmaceuticals, Inc. | 86 | 2021-09-28 | 2024-08-12 |
| A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease Carmustine 7.7Mg Wafer - Brain Tumor - Metastatic | Phase 2 | Recruiting | University of Nebraska | 100 | 2020-11-06 | 2026-04-28 |
| Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate Amphetamine Sulfate, Placebo - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Arbor Pharmaceuticals, Inc. | 320 | 2018-09-18 | 2024-09-03 |
| Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry CNS Tumor | Completed | Arbor Pharmaceuticals, Inc. | 272 | 2016-04-26 | 2025-11-10 | |
| Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets BiDil XR, BiDil Immediate Release (IR) - Heart Failure | Phase 1 | Completed | Arbor Pharmaceuticals, Inc. | 12 | 2015-09-01 | 2016-11-08 |
| HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder gabapentin enacarbil, Placebo - Alcohol Use Disorder | Phase 2 | Completed | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | 346 | 2015-06-01 | 2018-11-14 |
| An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension Azilsartan Medoxomil Low-dose, Losartan, Placebo for Azilsartan Medoxomil - Hypertension | Phase 3 | Completed | Arbor Pharmaceuticals, Inc. | 377 | 2015-03-30 | 2025-02-25 |
| Relative Bioavailability of AR10 Compared to Reference Product AR10, acetylcysteine - Healthy | Phase 1 | Completed | Arbor Pharmaceuticals, Inc. | 30 | 2014-04-01 | 2016-03-30 |
| Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS) AR08, Placebo - Vasomotor Symptoms (VMS) | Phase 2 | Terminated | Arbor Pharmaceuticals, Inc. | 32 | 2014-01-01 | 2015-12-09 |
| Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007) AR01, Placebo Comparator - Acute Otitis Media | Phase 3 | Terminated | Arbor Pharmaceuticals, Inc. | 178 | 2013-12-01 | 2017-01-24 |
| Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting AR11, Placebo - Attention Deficit Hyperactivity Disorder (ADHD) | Phase 4 | Completed | Arbor Pharmaceuticals, Inc. | 97 | 2013-12-01 | 2020-07-21 |
| Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media AR01, Glycerin ear drops - Acute Otitis Media | Phase 3 | Completed | Arbor Pharmaceuticals, Inc. | 304 | 2013-12-01 | 2015-04-08 |
| Phase I Rising-dose Study to Assess Tolerability, Safety, Pharmacokinetics, Pharmacodynamics of AR09 AR09 solution, placebo - Anesthesia | Phase 1 | Terminated | Arbor Pharmaceuticals, Inc. | 17 | 2013-12-01 | 2022-04-13 |
| AR08 for Treatment of ADHD in Children AR08, Placebo - ADHD | Phase 2 | Completed | Arbor Pharmaceuticals, Inc. | 122 | 2013-06-01 | 2015-12-09 |
| Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media benzocaine, placebo - Pain, Otitis Media | Phase 2 | Completed | Arbor Pharmaceuticals, Inc. | 38 | 2012-05-01 | 2015-05-04 |
| A Comparison of Various Combinations of BiDil Capsules and BiDil Tablets in Healthy Human Volunteers Isosorbide dinitrate / hydralazine capsules - Healthy | Phase 1 | Completed | Arbor Pharmaceuticals, Inc. | 36 | 2012-04-01 | 2015-08-06 |
Attention Deficit Disorder with Hyperactivity (3) · Otitis Media (3) · Pain (3) · Earache (2) · Otitis (2) · Alcohol Drinking (1) · Alcoholism (1) · Brain Neoplasms (1) · Central Nervous System Neoplasms (1) · Essential Hypertension (1) · Heart Failure (1) · Hypertension (1)
1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid (3) · Benzocaine (3) · Amphetamine (2) · Gabapentin (2) · Hydralazine (2) · Isosorbide Dinitrate (2) · Acetylcysteine (1) · Alprazolam (1) · Carmustine (1) · Losartan (1) · Oxycodone (1) · azilsartan medoxomil (1) · carmustine, poliferprosan 20 drug combination (1) · isosorbide-hydralazine combination (1)
United States (16) · Argentina (1) · Brazil (1) · Bulgaria (1) · Colombia (1) · Hungary (1) · Italy (1) · Mexico (1) · Poland (1) · South Africa (1) · Turkey (Türkiye) (1) · Ukraine (1)
Laurence Downey, MD (3) · Laurence J Downey, MD (2) · David MacLeod, MD (1) · Gregory J Tracey, MD (1) · Michele Aizenberg, MD (1) · Raye Z. Litten, Ph.D. (1) · Steve Caras, MD (1) · Steve D Caras, MD, PhD (1) · Steven Caras, MD, PhD (1) · Tania D Johnson, RN, BSN (1)