ZOGENIX, 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.
- 2023-01-11: Study NCT05560282; Company role Collaborator; Phase Phase 3; Status Terminated.
- 2022-10-20: Study NCT05232630; Company role Collaborator; Phase Phase 4; Status Unknown.
- 2022-03-08: Study NCT05064878; Company role Lead sponsor; Phase Phase 3; Status Active not recruiting.
- 2019-04-22: Study NCT03936777; Company role Lead sponsor; Phase Phase 3; Status Completed.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2023-01-11 | NCT05560282 Fenfluramine for Adult Dravet Patients | Collaborator Lead: University Health Network, Toronto | Phase 3 | Terminated | Dravet Syndrome; Dravet Syndrome, Intractable | 7 | 2025-05-13 |
| 2022-10-20 | NCT05232630 Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes | Collaborator Lead: Hospital Ruber Internacional | Phase 4 | Unknown | Refractory Epilepsy; SYNGAP1 Encephalopathy; STXBP1 Encephalopathy With Epilepsy; Inv Dup(15) Encephalopathy; Multifocal or Bilateral Malformations of Cortical Development; Continuous Spike and Waves During Slow Sleep | 20 | 2025-06-20 |
| 2022-03-08 | NCT05064878 A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder. | Lead sponsor | Phase 3 | Active not recruiting | CDKL5 Deficiency Disorder; Generalized Tonic Clonic Seizure; Epileptic Spasm; Refractory Seizures | 87 | 2027-11-08 |
| 2019-04-22 | NCT03936777 A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | Lead sponsor | Phase 3 | Completed Results posted | Dravet Syndrome; Lennox Gastaut Syndrome; Epileptic Encephalopathy | 412 | 2025-05-08 |
| 2019-03-14 | NCT04398667 European Non-interventional Study on Refractory Epilepsy With Developmental Delay | Lead sponsor | Observational | Terminated | Refractory Epilepsy; Development Delay | 93 | 2020-09-04 |
| 2016-01 | NCT02655198 Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy | Collaborator Lead: KU Leuven | Phase 2 | Unknown | Epilepsy; Lennox Gastaut Syndrome | 13 | 2024-12 |
| 2015-02 | NCT02411526 Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia | Lead sponsor | Phase 1 | Completed | Schizophrenia; Schizoaffective Disorder | 60 | 2015-09 |
| 2012-07 | NCT01592110 A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia | Lead sponsor | Phase 1 | Completed | Schizophrenia | 40 | 2013-04 |
| 2011-02 | NCT02244762 Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment | Lead sponsor | Phase 1 | Completed | Renal Impairment | 37 | 2011-05 |
| 2011-02 | NCT02242734 Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment | Lead sponsor | Phase 1 | Completed | Hepatic Impairment | 30 | 2011-05 |
| 2010-05 | NCT01115569 Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain | Lead sponsor | Phase 3 | Completed Results posted | Chronic Pain | 424 | 2012-01 |
| 2010-03 | NCT01081912 Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain | Lead sponsor | Phase 3 | Completed Results posted | Back Pain Lower Back Chronic | 510 | 2011-10 |
| 2009-11-30 | NCT01016834 Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine | Lead sponsor | Phase 4 | Completed Results posted | Migraine | 246 | 2010-04-30 |
| 2009-11 | NCT02126917 A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER) | Lead sponsor | Phase 1 | Completed | Healthy | 30 | 2009-12 |
| 2007-12 | NCT00620425 A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs | Lead sponsor | Phase 1 | Completed Results posted | Healthy | 18 | 2007-12 |
| 2007-09 | NCT00530517 A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack | Lead sponsor | Phase 2 | Completed | Migraine Headache | 54 | 2007-10 |
| 2007-07 | NCT00619554 A Study on the Intraject Instructions for Use | Lead sponsor | Observational | Completed | Healthy | 19 | |
| 2006-12 | NCT00614029 A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System | Lead sponsor | Phase 1 | Completed | Pharmacokinetics; Bioequivalence | 54 | |
| 2002-09 | NCT02222740 A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain | Lead sponsor | Phase 2 | Completed | Osteoarthrosis | 37 | 2002-12 |
| 2002-08 | NCT02197156 A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery | Lead sponsor | Phase 2 | Completed | Postoperative Pain | 241 | 2003-02 |
| 2002-06 | NCT02117141 To Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release Capsules | Lead sponsor | Phase 1 | Completed | Healthy | 12 | 2002-06 |
| NCT03780127 ZX008 Expanded Access Protocol | Lead sponsor | Expanded_access | Approved for marketing | Dravet Syndrome |