18 completed, 2 terminated, 1 active not recruiting, 1 approved for marketing. 8 Phase 1, 5 Phase 3, 4 Phase 2, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 8 |
| Phase 3 | 5 | Completed 3, Active not recruiting 1, Terminated 1 |
| Phase 2 | 4 | Completed 4 |
| 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 |
|---|---|---|---|---|---|---|
| Fenfluramine for Adult Dravet Patients Fenfluramine - Dravet Syndrome, Dravet Syndrome, Intractable | Phase 3 | Terminated | University Health Network, Toronto | 7 | 2023-01-11 | 2026-05-05 |
| Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes Fenfluramine - Refractory Epilepsy, SYNGAP1 Encephalopathy | Phase 4 | Completed | Hospital Ruber Internacional | 20 | 2022-10-20 | 2026-09-29 |
| A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder. Fenfluramine, Placebo - CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure | Phase 3 | Active not recruiting | Zogenix, Inc. | 87 | 2022-03-08 | 2026-04-29 |
| 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 ZX008 (Fenfluramine Hydrochloride) - Dravet Syndrome, Lennox Gastaut Syndrome | Phase 3 | Completed | Zogenix, Inc. | 412 | 2019-04-22 | 2025-11-17 |
| European Non-interventional Study on Refractory Epilepsy With Developmental Delay Refractory Epilepsy, Development Delay | Terminated | Zogenix, Inc. | 93 | 2019-03-14 | 2023-12-01 | |
| Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy Fenfluramine - Epilepsy, Lennox Gastaut Syndrome | Phase 2 | Completed | KU Leuven | 13 | 2016-01-01 | 2026-10-20 |
| Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia ZX003 (Risperidone-SABER®), Risperdal Consta, Oral Risperidone - Schizophrenia, Schizoaffective Disorder | Phase 1 | Completed | Zogenix, Inc. | 60 | 2015-02-01 | 2022-10-31 |
| A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia risperidone-SABER, ZX003:risperidone-SABER and the DosePro System, Risperidone-SABER - Schizophrenia | Phase 1 | Completed | Zogenix, Inc. | 40 | 2012-07-01 | 2022-11-10 |
| Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment 20 mg HC-ER - Renal Impairment | Phase 1 | Completed | Zogenix, Inc. | 37 | 2011-02-01 | 2022-11-10 |
| Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment 20 mg HC-ER - Hepatic Impairment | Phase 1 | Completed | Zogenix, Inc. | 30 | 2011-02-01 | 2022-11-10 |
| Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain Hydrocodone Bitartrate - Chronic Pain | Phase 3 | Completed | Zogenix, Inc. | 424 | 2010-05-01 | 2022-11-09 |
| Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain Placebo, Hydrocodone bitartrate - Back Pain Lower Back Chronic | Phase 3 | Completed | Zogenix, Inc. | 510 | 2010-03-01 | 2022-12-08 |
| Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine Sumavel DosePro, Sumatriptan - Migraine | Phase 4 | Completed | Zogenix, Inc. | 246 | 2009-11-30 | 2026-06-08 |
| A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER) HC-ER + 40% Alcohol, HC-ER + 20% Alcohol, HC-ER + 0% Alcohol - Healthy | Phase 1 | Completed | Zogenix, Inc. | 30 | 2009-11-01 | 2022-11-10 |
| A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs Sumatriptan - Healthy | Phase 1 | Completed | Zogenix, Inc. | 18 | 2007-12-01 | 2023-05-09 |
| A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack Intraject Sumatriptan - Migraine Headache | Phase 2 | Completed | Zogenix, Inc. | 54 | 2007-09-01 | 2022-11-10 |
| A Study on the Intraject Instructions for Use Healthy | Completed | Zogenix, Inc. | 19 | 2007-07-01 | 2022-11-10 | |
| A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System Sumatriptan (via Intraject System) - Pharmacokinetics, Bioequivalence | Phase 1 | Completed | Zogenix, Inc. | 54 | 2006-12-01 | 2022-11-10 |
| A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain 10 mg of Hydrocodone Bitartrate Extended Release (HC-ER), 20 mg of Hydrocodone Bitartrate Extended Release (HC-ER) - Osteoarthrosis | Phase 2 | Completed | Zogenix, Inc. | 37 | 2002-09-01 | 2022-11-10 |
| A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery 10 mg HC-ER, 20 mg HC-ER, 30 mg HC-ER - Postoperative Pain | Phase 2 | Completed | Zogenix, Inc. | 241 | 2002-08-01 | 2022-11-10 |
Showing 20 of 22. Sign in to see all of them.
Epilepsies, Myoclonic (3) · Chronic Pain (2) · Drug Resistant Epilepsy (2) · Epilepsy (2) · Lennox Gastaut Syndrome (2) · Migraine Disorders (2) · Schizophrenia (2) · Back Pain (1) · Brain Diseases (1) · CDKL5 deficiency disorder (1) · Chromosome 15q, tetrasomy (1) · Epilepsy, Tonic-Clonic (1) · Epileptic Encephalopathy, Early Infantile, 4 (1) · Genetic Diseases, Inborn (1) · Learning Disabilities (1)
Hydrocodone (8) · Fenfluramine (6) · Sumatriptan (2) · Acetaminophen (1) · Ethanol (1) · Risperidone (1) · Sugars (1)
United States (9) · Spain (4) · Belgium (3) · Germany (3) · Italy (3) · Canada (2) · France (2) · Netherlands (2) · United Kingdom (2) · Australia (1) · Austria (1) · Denmark (1) · Georgia (1) · Ireland (1) · Israel (1)
Kenneth Lasseter, MD (2) · Patricia Chandler, MD (2) · A. Johnston Stewart, MB, MRCGP (1) · Antonio Gil-Nagel, MD, PHD (1) · David Walling, PhD (1) · James Kissling, MD (1) · Jan Brandes, MD (1) · Kevin Romanko, DPM (1) · Lev G Gertsik, MD (1) · Lieven G Lagae, MD, PhD (1) · Roger K Cady, MD (1) · Vickie Gorgone (1)
PMID 21812775, PMID 21942531, PMID 30146701, PMID 34768178
2019 (1), 2023 (1)