19 completed, 2 terminated. 8 Phase 2, 6 Phase 1, 5 Phase 3, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 8 |
| Phase 1 | 6 | Completed 6 |
| Phase 3 | 5 | Completed 5 |
| Phase 4 | 3 | Terminated 2, Completed 1 |
Follow this drug Literature Review of dextromethorphan - quinidine combination trials Research Report on dextromethorphan - quinidine combination
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 |
|---|---|---|---|---|---|---|
| Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg), Placebo - Huntington Disease, Irritability | Phase 3 | Completed | The University of Texas Health Science Center, Houston | 20 | 2019-08-05 | 2024-01-05 |
| Impact of Nuedexta on Bulbar Physiology and Function in ALS dextromethorphan HBr and quinidine sulfate - Amyotrophic Lateral Sclerosis | Phase 1 / Phase 2 | Completed | University of Florida | 28 | 2019-07-25 | 2023-03-08 |
| 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 |
| Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts AVP-923, AVP-786, Itraconazole - Healthy | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 24 | 2015-03-01 | 2026-04-28 |
| 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 |
| A Phase 1 Study Comparing AVP-786 With AVP-923 AVP-786, AVP-923 - Healthy Volunteer | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 62 | 2014-05-01 | 2026-04-28 |
| 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 |
| A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers AVP-786, AVP-923 - Healthy | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 56 | 2013-09-01 | 2026-04-28 |
| Nuedexta in Treatment-Resistant Major Depression dextromethorphan/quinidine - Major Depressive Disorder, Treatment Resistant | Phase 2 | Completed | James Murrough | 20 | 2013-07-01 | 2018-06-11 |
| Clinical Trial Nuedexta in Subjects With ALS Nuedexta, Matching Placebo - Amyotrophic Lateral Sclerosis (ALS) | Phase 2 | Completed | Center for Neurologic Study, La Jolla, California, | 90 | 2013-04-01 | 2017-03-24 |
| 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 |
| Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers AVP-786 Dose 1, AVP-786 Dose 2, AVP-786 Dose 1/Q Dose 1 - Healthy | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 48 | 2012-10-01 | 2026-04-28 |
| 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 |
| Nuedexta for the Treatment of Adults With Autism Nuedexta, Placebo - Autism | Phase 2 | Completed | Sutter Health | 13 | 2012-01-24 | 2017-12-08 |
| 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 |
| 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 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 |
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Amyotrophic Lateral Sclerosis (4) · Alzheimer Disease (3) · Multiple Sclerosis (3) · Brain Injuries, Traumatic (2) · Parkinson Disease (2) · Stroke (2) · Aggression (1) · Autistic Disorder (1) · Crying (1) · Dementia (1) · Depression (1) · Depressive Disorder, Major (1) · Dyskinesias (1) · Headache (1) · Huntington Disease (1)
Avanir Pharmaceuticals (10) · Otsuka Pharmaceutical Development & Commercialization, Inc. (4) · Cady, Roger, M.D. (1) · Center for Neurologic Study, La Jolla, California, (1) · James Murrough (1) · St. Joseph's Hospital and Medical Center, Phoenix (1) · Sutter Health (1) · The University of Texas Health Science Center, Houston (1) · University of Florida (1)
United States (19) · Argentina (2) · Australia (2) · Brazil (1) · Canada (1) · Czechia (1) · Poland (1) · Spain (1)
Adrian Hepner, M.D. (1) · Carol A Parise, PhD (1) · Emily Plowman, PhD (1) · Erin L Furr Stimming, MD (1) · James Murrough, MD (1) · Jeremy Shefner, MD, PhD (1) · Jiong Shi, MD, PhD (1) · Lauren Tabor, PhD (1) · Merit E Cudkowicz, MD, MSc (1) · Michael G Chez, MD (1) · Richard A Smith, MD (1)
PMID 15505150, PMID 16634036, PMID 20839238, PMID 25062507, PMID 26471212, PMID 27276999, PMID 28370447, PMID 28478356, PMID 29477412, PMID 41499296