Insys Therapeutics, Inc. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2018-04-23: Study NCT03827642; Company role Lead sponsor; Phase Phase 1; Status Completed.
- 2017-12-30: Study NCT02318563; Company role Lead sponsor; Phase Phase 3; Status Withdrawn.
- 2017-12-30: Study NCT02318537; Company role Lead sponsor; Phase Phase 3; Status Withdrawn.
- 2017-12-30: Study NCT02138409; Company role Lead sponsor; Phase Phase 3; Status Withdrawn.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2018-04-23 | NCT03827642 A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy Volunteer | 24 | 2018-05-06 |
| 2017-12-30 | NCT02318563 Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome | Lead sponsor | Phase 3 | Withdrawn | Dravet Syndrome | 0 | 2018-06-17 |
| 2017-12-30 | NCT02318537 Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome | Lead sponsor | Phase 3 | Withdrawn | Lennox-Gastaut Syndrome | 0 | 2018-06-30 |
| 2017-12-30 | NCT02138409 Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting | Lead sponsor | Phase 3 | Withdrawn | Chronic Pain | 0 | 2018-01 |
| 2017-09-12 | NCT03254459 Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain | Lead sponsor | Phase 2 | Completed Results posted | Pain, Postoperative | 100 | 2017-11-13 |
| 2017-08-07 | NCT03827629 A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy Volunteer | 24 | 2017-08-16 |
| 2016-12 | NCT02915978 Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain | Lead sponsor | Phase 2 | Completed Results posted | Pain | 45 | 2017-02-10 |
| 2016-07 | NCT02751359 Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers | Collaborator Lead: University of California, Los Angeles | Phase 1, Phase 2 | Completed Results posted | Pain | 18 | 2020-04 |
| 2016-02-02 | NCT02514252 Sublingual Fentanyl for the Management of Breakthrough Pain | Collaborator Lead: M.D. Anderson Cancer Center | Phase 2 | Terminated Results posted | Advanced Cancers | 6 | 2019-11-04 |
| 2016-01-29 | NCT02634788 Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain | Lead sponsor | Phase 3 | Completed Results posted | Pain | 322 | 2016-06-24 |
| 2016-01-27 | NCT02551731 Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms | Lead sponsor | Phase 2 | Terminated Results posted | Spasms, Infantile | 9 | 2016-09-06 |
| 2016-01-08 | NCT02318602 Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder | Lead sponsor | Phase 3 | Completed Results posted | Seizures | 52 | 2017-06-22 |
| 2016-01-04 | NCT02597478 Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea | Collaborator Lead: M.D. Anderson Cancer Center | Phase 2, Phase 3 | Completed Results posted | Advanced Cancers | 50 | 2021-01-27 |
| 2016-01 | NCT02641340 Fentanyl Sublingual Spray in Opioid Naive Participants | Lead sponsor | Phase 1 | Completed | Pharmacology | 96 | 2016-03 |
| 2015-11 | NCT02604992 Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers | Lead sponsor | Not applicable | Completed | Healthy | 54 | 2015-12 |
| 2015-10 | NCT02576353 Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects | Lead sponsor | Phase 1 | Completed | Pharmacokinetics and Pharmacodynamics | 50 | 2015-11 |
| 2015-06 | NCT02477267 Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Opiate Dependence | 47 | 2015-07 |
| 2015-04-13 | NCT02324673 Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Seizures | 61 | 2016-05-09 |
| 2015-02-24 | NCT02310581 Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain | Lead sponsor | Phase 3 | Terminated Results posted | Post-operative Pain | 40 | 2015-03-19 |
| 2014-02 | NCT02094599 A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users | Lead sponsor | Phase 1 | Completed | Drug Abuse, Medication | 43 | 2014-05 |
| 2014-01 | NCT02138396 Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions | Lead sponsor | Not applicable | Completed | Bioavailability | 12 | 2014-01 |
| 2013-02 | NCT02902081 Cannabidiol and Emotional Stimuli | Collaborator Lead: University of Chicago | Not applicable | Completed Results posted | Drug Addiction | 38 | 2017-03 |
| 2012-12 | NCT01832974 Possible New Therapy for Advanced Cancer | Lead sponsor | Phase 1 | Terminated | Adrenocortical Carcinoma | 9 | 2014-09 |
| 2011-10 | NCT01448772 Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions | Lead sponsor | Phase 1 | Completed | Bioavailability | 88 | 2011-12 |
| 2010-06 | NCT01188408 Efficacy and Safety Study of LE-DT to Treat Metastatic Castrate Resistant Prostate Cancer | Lead sponsor | Phase 2 | Withdrawn | Prostate Cancer | 0 | 2011-09 |
| 2010-04 | NCT01186731 Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer | Lead sponsor | Phase 2 | Completed | Pancreatic Cancer | 40 | 2011-12 |
| 2009-10 | NCT00956254 Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis | Lead sponsor | Phase 3 | Completed Results posted | Mucositis; Pain; Unspecified Adult Solid Tumor, Protocol Specific | 18 | 2010-10 |
| 2008-03 | NCT01190982 Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer | Lead sponsor | Phase 2 | Completed | Breast Cancer | 70 | 2011-12 |
| 2008-02 | NCT01151384 Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors | Lead sponsor | Phase 1 | Completed | Solid Tumors | 30 | 2010-05 |
| 2007-12 | NCT00538863 Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain | Lead sponsor | Phase 3 | Completed Results posted | Cancer; Pain | 319 | 2010-10 |
| 2007-10 | NCT00538850 Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain | Lead sponsor | Phase 3 | Completed Results posted | Cancer | 130 | 2010-10 |
| 2007-04 | NCT01780233 Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv) | Lead sponsor | Phase 1 | Completed | Pain | 40 | 2007-05 |
| 2004-12 | NCT00100672 Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer | Lead sponsor | Phase 1 | Completed | Neoplasms | 40 | 2010-11 |
| 2004-11 | NCT00100139 Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer | Lead sponsor | Phase 1 | Completed | Neoplasm | 48 | 2010-06 |
| 2004-07 | NCT00089427 IL13-PE38QQR Infusion After Tumor Resection, Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma | Lead sponsor | Phase 1 | Completed | Glioblastoma Multiforme; Anaplastic Astrocytoma; Oligoastrocytoma | 24 | |
| 2004-02 | NCT00076986 The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme | Lead sponsor | Phase 3 | Completed | Glioblastoma Multiforme | 300 | 2007-03 |
| 2003-07 | NCT00080418 Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer | Lead sponsor | Phase 1 | Completed | Neoplasm | 40 | 2010-06 |
| 2003-07 | NCT00064779 Imaging Study of the Distribution of IL13-PE38QQR Infused Before and After Surgery in Adult Patients With Recurrent Malignant Glioma | Lead sponsor | Phase 1 | Completed | Malignant Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Mixed Oligoastrocytoma | 18 | 2007-07 |
| 2002-10 | NCT00046540 Liposome Encapsulated SN38 (LE-SN38) in Patients With Advanced Cancer | Lead sponsor | Phase 1 | Completed | Neoplasms | 40 | 2010-11 |
| 2002-07 | NCT00041587 Pre-operative IL13-PE38QQR in Patients With Recurrent or Progressive Malignant Glioma | Lead sponsor | Phase 1, Phase 2 | Completed | Malignant Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Mixed Oligoastrocytoma | 80 | 2007-07 |
| 2001-08 | NCT00024492 Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer | Lead sponsor | Phase 1 | Completed | Tumors | 40 | 2004-06 |
| 2001-06 | NCT00024557 Histologic Effect/Safety of Pre/Post-Operative IL13-PE38QQR in Recurrent Resectable Supratentorial Malignant Glioma Patients | Lead sponsor | Phase 1 | Completed | Malignant Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Mixed Oligoastrocytoma; Malignant Astrocytoma | 40 | 2007-07 |
| 2001-03 | NCT00024661 Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Solid Tumors | Lead sponsor | Phase 1 | Completed | Neoplasms | 30 | 2004-10 |
| 2001-03 | NCT00024648 Study to Determine Maximum Tolerated Dose of LErafAON Combined With Radiotherapy in Patients With Advanced Malignancies | Lead sponsor | Phase 1 | Completed | Neoplasms | 25 | 2004-12 |
| 2001-02 | NCT00024674 Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion for 10 Days | Lead sponsor | Phase 1 | Withdrawn | Neoplasms | 0 | |
| 2000-11 | NCT00024687 Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: IV Infusion QOD x Six Doses | Lead sponsor | Phase 1 | Withdrawn | Neoplasms | 0 | |
| 2000-11 | NCT00024570 Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma | Lead sponsor | Phase 1, Phase 2 | Completed | Malignant Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Mixed Oligoastrocytoma | 60 | 2007-07 |
| NCT02137525 Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain | Lead sponsor | Phase 2 | Withdrawn | Acute Pain | 0 | ||
| NCT00378235 Phase I/II Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma | Lead sponsor | Phase 1, Phase 2 | Withdrawn | Recurrent Malignant Glioma | 0 |