17 completed, 4 terminated, 1 suspended, 1 unknown. 6 Phase 1, 5 Phase 3, 4 Phase 4, 3 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 6 |
| Phase 3 | 5 | Completed 2, Terminated 2, Unknown 1 |
| Phase 4 | 4 | Completed 3, Terminated 1 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Not applicable | 1 | Completed 1 |
Follow Loxapine: new trials by email Literature Review of Loxapine trials Research Report on Loxapine
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 |
|---|---|---|---|---|---|---|
| AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine Intranasal midazolam, Intramuscular loxapine - Emergence Delirium | Phase 3 | Terminated | Assistance Publique - Hôpitaux de Paris | 1 | 2023-04-09 | 2024-05-28 |
| A Study of Staccato Loxapine (ADASUVE®) for Inhalation Inhaled loxapine, Inhaled placebo - Psychomotor Agitation, Schizophrenia | Phase 3 | Unknown | Lee's Pharmaceutical Limited | 150 | 2019-12-01 | 2019-11-05 |
| Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation Haloperidol + lorazepam, Loxapine - Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use | Phase 4 | Terminated | University of Arkansas | 2 | 2017-09-30 | 2018-06-11 |
| Tolerability and Analgesic Efficacy of Loxapine in Patients With Refractory, Chemotherapy-induced Neuropathic Pain Loxapine - Neuropathic Pain | Phase 2 | Terminated | University of Witten/Herdecke | 4 | 2016-06-07 | 2022-07-01 |
| Family Intervention in Recent Onset Schizophrenia Treatment (FIRST) Caregiver psycho-education and skills training, Caregiver support available at the study site, Paliperidone palmitate - Schizophrenia | Completed | Janssen Scientific Affairs, LLC | 296 | 2015-07-24 | 2019-01-23 | |
| Outcomes of Antipsychotic Medication Used in the Emergency Department Adasuve, Alternative medications - Agitation,Psychomotor | Completed | Wake Forest University Health Sciences | 93 | 2015-04-01 | 2024-10-04 | |
| Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder Loxapine 10 MG - Agitation,Psychomotor | Suspended | Alexza Pharmaceuticals, Inc. | 10000 | 2014-11-04 | 2025-10-21 | |
| Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication ADASUVE® - BiPolar | Phase 1 | Completed | Teva Branded Pharmaceutical Products R&D, Inc. | 30 | 2014-07-01 | 2021-11-12 |
| ADASUVE-Lorazepam Drug-Drug Interaction Lorazepam 1 mg IM, Inhaled loxapine 10 mg, Inhaled Placebo - Healthy Volunteers | Phase 4 | Completed | Alexza Pharmaceuticals, Inc. | 22 | 2013-06-01 | 2017-12-13 |
| ADASUVE 2-dose Thorough QT/QTc Study ADASUVE 10 mg 2 doses 2 hours apart, Inhaled Placebo, Oral moxifloxacin 400 mg - Healthy Volunteers | Phase 4 | Completed | Alexza Pharmaceuticals, Inc. | 60 | 2013-05-01 | 2017-10-18 |
| Antipsychotics and Risk of Hyperglycemic Emergencies Olanzapine, Risperidone, atypical antipsychotics (other) - Psychotic Disorders, Schizophrenia | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | 725489 | 2012-04-01 | 2015-10-21 | |
| Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning loxapine, Placebo - Restlessness | Phase 4 | Completed | Assistance Publique - Hôpitaux de Paris | 100 | 2011-05-01 | 2014-07-18 |
| Staccato Loxapine Pulmonary Safety in Patients With Asthma Inhaled loxapine @ 0 & 10 h, Inhaled placebo @ 2 & 10 hours - Asthma | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 52 | 2009-05-01 | 2017-03-15 |
| Staccato Loxapine Thorough QT/QTc Study Inhaled loxapine, Inhaled placebo, Oral moxifloxacin - Thorough QT/QTc Study | Phase 1 | Completed | Nova Pneuma Inc. | 48 | 2009-04-01 | 2026-04-22 |
| Staccato Loxapine in Agitated Patients With Bipolar Disorder Inhaled Placebo, Inhaled loxapine 5 mg, Inhaled loxapine 10 mg - Bipolar I Disorder | Phase 3 | Completed | Alexza Pharmaceuticals, Inc. | 314 | 2008-07-01 | 2017-07-26 |
| Staccato Loxapine in Agitated Patients With Schizophrenia Inhaled loxapine 5 mg, Inhaled loxapine 10 mg, Inhaled placebo - Patients With Schizophrenia and Acute Agitation | Phase 3 | Completed | Alexza Pharmaceuticals, Inc. | 344 | 2008-02-01 | 2017-07-26 |
| Staccato Prochlorperazine Thorough QT/QTc Inhaled placebo, Oral placebo, Inhaled prochlorperazine 5 mg - Cardiotoxicity | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 48 | 2007-10-01 | 2019-03-11 |
| Staccato Loxapine in Migraine (in Clinic) Staccato Loxapine, Staccato Placebo - Migraine | Phase 2 | Completed | Alexza Pharmaceuticals, Inc. | 168 | 2007-06-01 | 2017-07-06 |
| Staccato Loxapine in Agitation (Proof of Concept) Inhaled Placebo, Inhaled Loxapine 5 mg, Inhaled Loxapine 10 mg - Schizophrenia | Phase 2 | Completed | Alexza Pharmaceuticals, Inc. | 129 | 2006-08-01 | 2018-01-02 |
| Loxapine and Weaning From Ventilator loxapine - Respiratory Insufficiency, Psychomotor Agitation | Not applicable | Completed | Assistance Publique - Hôpitaux de Paris | 9 | 2005-12-01 | 2007-07-23 |
Showing 20 of 23. Sign in to see all of them.
Psychomotor Agitation (10) · Schizophrenia (8) · Bipolar Disorder (2) · Asthma (1) · Cardiotoxicity (1) · Diabetes Mellitus (1) · Diabetes Mellitus, Type 2 (1) · Drug-Related Side Effects and Adverse Reactions (1) · Emergence Delirium (1) · Emergencies (1) · Migraine Disorders (1) · Neuralgia (1) · Psychotic Disorders (1) · Respiratory Insufficiency (1)
Alexza Pharmaceuticals, Inc. (10) · Assistance Publique - Hôpitaux de Paris (3) · Canadian Network for Observational Drug Effect Studies, CNODES (1) · Janssen Scientific Affairs, LLC (1) · Lee's Pharmaceutical Limited (1) · Mylan Pharmaceuticals Inc (1) · Nova Pneuma Inc. (1) · Teva Branded Pharmaceutical Products R&D, Inc. (1) · University Hospital, Rouen (1) · University of Arkansas (1) · University of Witten/Herdecke (1) · Wake Forest University Health Sciences (1)
United States (14) · France (4) · Canada (1) · Germany (1) · Netherlands (1)
Randall R Stoltz, MD (2) · Robert S Fishman, MD (2) · Daniel Zimbroff, MD (1) · Didier Dreyfuss, MD (1) · Egilius Spierings, MD (1) · Erik Kulstad, MD (1) · Fabienne FM Moritz, MD (1) · Lorraine Lipscombe, MD, MSc (1) · Michael P Wilson, MD (1) · Mildred D. Gottwald, PharmD (1) · Randall R. Stoltz, MD (1) · Randall Stoltz, MD (1)
PMID 29163985, PMID 19915181, PMID 20528148, PMID 21294997, PMID 24375070, PMID 24581419, PMID 25210413, PMID 26445139, PMID 27022468, PMID 28205038, PMID 28877705, PMID 31402867, PMID 35436231
2014 (1)