24 completed, 1 suspended, 1 terminated. 13 Phase 1, 8 Phase 2, 2 Phase 3, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 13 | Completed 13 |
| Phase 2 | 8 | Completed 7, Terminated 1 |
| Phase 3 | 2 | Completed 2 |
| Phase 4 | 2 | Completed 2 |
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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 Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes Apomorphine Cartridge - Parkinson Disease | Phase 2 | Terminated | Alexza Pharmaceuticals, Inc. | 8 | 2023-09-27 | 2025-10-21 |
| Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome 3mg AZ-010, 1mg AZ010, Staccato Placebo - Cyclic Vomiting Syndrome | Phase 2 | Completed | Alexza Pharmaceuticals, Inc. | 150 | 2021-02-05 | 2025-06-11 |
| Staccato® Granisetron Multiple Dose PK 0.5mg AZ-010, 1mg AZ-010, 3mg AZ-010 - Healthy | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 30 | 2020-03-10 | 2020-10-30 |
| Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease 009-A1, 009-A2, 009-A3 - Parkinson's Disease | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 35 | 2019-10-16 | 2020-11-04 |
| Staccato Apomorphine Single and Multi Dose PK 009-1, active comparator, 009-0 - Parkinson Disease | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 56 | 2018-11-26 | 2019-08-30 |
| 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 | |
| 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 |
| Staccato Loxapine Pulmonary Safety in Patients With COPD Inhaled Loxapine, Inhaled Placebo - Chronic Obstructive Pulmonary Disease | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 53 | 2009-06-01 | 2017-03-14 |
| 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 PK in Smokers and Nonsmokers Inhaled Loxapine 10 mg - Smoking, Cigarette | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 35 | 2009-04-01 | 2017-03-15 |
| Staccato Loxapine in Migraine (Out Patient) Inhaled Placebo, Inhaled Loxapine 1.25 mg, Inhaled Loxapine 2.5 mg - Migraine Headache | Phase 2 | Completed | Alexza Pharmaceuticals, Inc. | 366 | 2009-01-01 | 2017-04-24 |
| Staccato Loxapine Pulmonary Safety in Healthy Volunteers Inhaled Placebo, Inhaled Loxapine - Healthy | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 30 | 2008-11-01 | 2019-03-11 |
| 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 Zaleplon Single Dose Pharmacokinetics Inhaled placebo, Inhaled Zaleplon 0.5 mg, Inhaled Zaleplon 1 mg - Healthy | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 40 | 2008-02-01 | 2017-03-14 |
| Staccato Loxapine Multidose PK A - 10 mg loxapine q 4 h x 3 (30 mg total), B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total), C - 5 mg loxapine q 4 h x 3 (15 mg total) - Volunteers on Chronic, Stable Antipsychotic Regimens | Phase 1 | Completed | Alexza Pharmaceuticals, Inc. | 40 | 2007-10-01 | 2017-03-15 |
| 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 Alprazolam in Panic Attack Inhaled placebo, Inhaled alprazolam 1 mg, Inhaled alprazolam 2 mg - Treatment of Induced Panic Attack | Phase 2 | Completed | Alexza Pharmaceuticals, Inc. | 49 | 2007-05-01 | 2017-06-16 |
Showing 20 of 26. Sign in to see all of them.
Migraine Disorders (5) · Psychomotor Agitation (4) · Schizophrenia (4) · Parkinson Disease (3) · Panic Disorder (2) · Abdominal Pain (1) · Asthma (1) · Breakthrough Pain (1) · Cardiotoxicity (1) · Cigarette Smoking (1) · Epilepsy (1) · Familial cyclic vomiting syndrome (1) · Foodborne Diseases (1) · Nausea (1) · Pulmonary Disease, Chronic Obstructive (1)
Loxapine (10) · Moxifloxacin (2) · Crossing Over, Genetic (1) · Doxapram (1) · Lorazepam (1) · Sodium Chloride (1)
United States (22) · Netherlands (3)
Arthur Elkind, MD (2) · Geert J Groeneveld, MD, PhD (2) · Mildred D. Gottwald, PharmD (2) · Randall R Stoltz, MD (2) · Randall Stoltz, MD (2) · Robert S Fishman, MD (2) · Daniel A Spyker, MD (1) · Daniel A Spyker, PhD, MD (1) · Daniel Zimbroff, MD (1) · David S. Miller, MD (1) · Egilius LH Spierings, MD (1) · Egilius Spierings, MD (1) · Fred Freitag, DO (1) · Jeremy Coplan, MD (1) · Larry Carter, PhD (1)
PMID 29163985, PMID 19915181, PMID 21294997, PMID 26445139, PMID 27022468