13 completed, 2 terminated. 6 Phase 3, 4 Phase 2, 3 Phase 4, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 6 |
| Phase 2 | 4 | Completed 4 |
| Phase 4 | 3 | Terminated 2, Completed 1 |
| 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 |
|---|---|---|---|---|---|---|
| Study to Assess the Bioavailability, Pharmacokinetics, Safety, and Tolerability of AVP-923 in Healthy Adult Participants AVP-923 - Healthy Adult Male and Female Volunteers | Phase 1 | Completed | Avanir Pharmaceuticals | 17 | 2017-11-28 | 2018-02-23 |
| Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA) NUEDEXTA® - Pseudobulbar Affect (Involuntary Laughing and/or Crying) | Phase 4 | Terminated | Avanir Pharmaceuticals | 5 | 2015-09-01 | 2017-07-03 |
| Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine Dextromethorphan and quinidine, Placebo - Episodic Migraine | Phase 2 | Completed | Cady, Roger, M.D. | 76 | 2014-08-01 | 2018-04-03 |
| Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients AVP-923-45, Placebo - Dyskinesia, Parkinson's Disease | Phase 2 | Completed | Avanir Pharmaceuticals | 14 | 2013-10-16 | 2022-04-29 |
| Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA) Nuedexta (DM 20 mg/Q 10 mg) - Pseudobulbar Affect (PBA), Stroke | Phase 4 | Completed | Avanir Pharmaceuticals | 367 | 2013-02-01 | 2017-03-15 |
| Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease Nuedexta (20/10) - Alzheimer's Disease, Pseudobulbar Affect (PBA) | Phase 4 | Terminated | St. Joseph's Hospital and Medical Center, Phoenix | 34 | 2012-08-28 | 2019-10-29 |
| Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease AVP-923-20, Placebo, AVP-923-30 - Agitation, Alzheimer's Disease | Phase 2 | Completed | Avanir Pharmaceuticals | 220 | 2012-08-13 | 2021-11-26 |
| Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally, OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet - Migraine, Headaches | Phase 3 | Completed | Avanir Pharmaceuticals | 275 | 2012-08-01 | 2017-04-12 |
| Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis AVP-923-45, AVP-923-30, AVP-923-20 - Central Neuropathic Pain, Multiple Sclerosis | Phase 2 | Completed | Avanir Pharmaceuticals | 209 | 2011-09-08 | 2021-11-22 |
| PRISM Registry: Pseudobulbar Affect Registry Series Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS) | Completed | Avanir Pharmaceuticals | 5290 | 2011-05-01 | 2014-04-16 | |
| Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg, dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg, Placebo - Pseudobulbar Affect (PBA) | Phase 3 | Completed | Avanir Pharmaceuticals | 326 | 2007-12-01 | 2017-04-12 |
| Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy Neurodex - Pain, Diabetic Neuropathy | Phase 3 | Completed | Avanir Pharmaceuticals | 450 | 2005-07-01 | 2016-07-14 |
| Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter) AVP-923 - Alzheimer's Disease, Stroke | Phase 3 | Completed | Avanir Pharmaceuticals | 600 | 2003-02-01 | 2016-07-14 |
| Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients AVP-923 - Multiple Sclerosis | Phase 3 | Completed | Avanir Pharmaceuticals | 96 | 2002-12-01 | 2016-07-14 |
| Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS AVP-923 - Amyotrophic Lateral Sclerosis | Phase 3 | Completed | Avanir Pharmaceuticals | 100 | 2001-01-01 | 2016-07-14 |
Alzheimer Disease (4) · Multiple Sclerosis (4) · Amyotrophic Lateral Sclerosis (3) · Brain Injuries, Traumatic (3) · Parkinson Disease (3) · Stroke (3) · Headache (2) · Migraine Disorders (2) · Aggression (1) · Crying (1) · Dementia (1) · Diabetic Neuropathies (1) · Dyskinesias (1) · Laughter (1) · Pain (1)
dextromethorphan - quinidine combination (12) · Dextromethorphan (3) · Quinidine (3) · Sumatriptan (1)
United States (15) · Argentina (2) · Brazil (1) · Canada (1) · Czechia (1) · Poland (1) · Spain (1)
Adrian Hepner, M.D. (1) · Jiong Shi, MD, PhD (1) · Randall Kaye, MD (1)
PMID 15505150, PMID 16634036, PMID 20839238, PMID 22314263, PMID 25062507, PMID 25941016, PMID 26471212, PMID 27276999, PMID 28370447, PMID 28880380, PMID 29477412