15 completed, 3 withdrawn, 1 recruiting, 1 terminated. 7 Phase 3, 5 Phase 2, 2 Phase 4, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 5, Withdrawn 2 |
| Phase 2 | 5 | Completed 2, Recruiting 1, Terminated 1, Withdrawn 1 |
| Phase 4 | 2 | Completed 1, Withdrawn 1 |
| Not applicable | 1 | Completed 1 |
Follow Infantile Spasms: new trials by email Literature Review of Infantile Spasms trials Research Report on Infantile Spasms
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 |
|---|---|---|---|---|---|---|
| A Study to Prevent Infantile Spasms Relapse Prednisolone, Famotidine, Placebo - Infantile Spasms, Infantile Epileptic Spasms Syndrome | Phase 2 | Recruiting | University of California, Los Angeles | 40 | 2025-05-05 | 2025-05-08 |
| Artificial Intelligence-based Video Analysis to Detect Infantile Spasms Spasm Vision - Infantile Spasms | Completed | Johns Hopkins University | 61 | 2024-08-26 | 2026-05-07 | |
| Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms Prednisolone, Vigabatrin - Infantile Spasms | Phase 3 | Withdrawn | The Hospital for Sick Children | 2017-09-05 | 2019-11-14 | |
| Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7) GWP42003-P - Infantile Spasms | Phase 3 | Completed | Jazz Pharmaceuticals | 9 | 2017-05-12 | 2022-09-02 |
| Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7) GWP42003-P - Infantile Spasms | Phase 3 | Completed | Jazz Pharmaceuticals | 9 | 2017-04-24 | 2022-09-02 |
| Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy Vigabatrin: Vigabatrin new ST formulation then Sabril® - Infantile Spasms | Not applicable | Completed | Orphelia Pharma | 38 | 2014-05-01 | 2018-04-24 |
| Evaluation of Neuroinflammation in Children With Infantile Spasms ACTH - Infantile Spasms | Phase 4 | Completed | Wayne State University | 8 | 2013-03-01 | 2017-11-07 |
| Genetic Studies in Patients and Families With Infantile Spasms Infantile Spasms | Completed | University of Colorado, Denver | 63 | 2013-03-01 | 2021-06-14 | |
| Addition of Pyridoxine to Prednisolone in Infantile Spasms Pyridoxine plus prednisolone, Prednisolone - Infantile Spasms | Phase 3 | Completed | Lady Hardinge Medical College | 62 | 2012-11-01 | 2019-01-15 |
| An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms Vigabatrin - Infantile Spasms | Phase 4 | Withdrawn | Lundbeck LLC | 2012-06-01 | 2012-09-13 | |
| Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy modified Atkins diet, no dietetic input - Infantile Spasms | Phase 2 / Phase 3 | Withdrawn | Lady Hardinge Medical College | 2012-02-01 | 2013-04-09 | |
| Prednisolone in Infantile Spasms- High Dose Versus Usual Dose Oral prednisolone - Infantile Spasms, West Syndrome | Phase 3 | Completed | Lady Hardinge Medical College | 63 | 2012-02-01 | 2013-04-09 |
| Molecular Genetics in Infantile Spasms Infantile Spasms, West Syndrome | Completed | Hospices Civils de Lyon | 41 | 2010-10-01 | 2016-08-31 | |
| Use of the Modified Atkins Diet in Infantile Spasms modified Atkins diet - Infantile Spasms | Phase 2 / Phase 3 | Completed | All India Institute of Medical Sciences | 15 | 2009-10-01 | 2010-11-22 |
| Sabril Patient Registry Sabril® - Infantile Spasms, Refractory Complex Partial Seizures in Adults | Completed | Lundbeck LLC | 9423 | 2009-08-01 | 2016-07-29 | |
| Epilepsy Phenome/Genome Project Epilepsy, Localization-related Epilepsy | Completed | University of California, San Francisco | 4150 | 2007-11-01 | 2018-11-13 | |
| Open-label Extension to Protocol 1042-0500 Ganaxolone - Infantile Spasms | Phase 2 | Terminated | Marinus Pharmaceuticals | 54 | 2007-01-01 | 2024-05-28 |
| A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms Ganaxolone, Placebo - Infantile Spasms | Phase 2 | Completed | Marinus Pharmaceuticals | 57 | 2007-01-01 | 2023-06-02 |
| Metabolic Abnormalities in Children With Epilepsy 18 FDG - Generalized Epilepsy, Infantile Spasms | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | 80 | 1992-04-01 | 2008-03-04 | |
| Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study Infantile Spasms | Completed | Yonsei University | 2009-08-28 |
Spasms, Infantile (20) · Seizures (3) · Epilepsies, Partial (2) · Epilepsy (2) · Lennox Gastaut Syndrome (2) · Epilepsy, Complex Partial (1) · Epilepsy, Generalized (1) · Epilepsy, Idiopathic Generalized (1) · Malformations of Cortical Development (1) · Metabolic Diseases (1) · Neuroinflammatory Diseases (1) · Periventricular Nodular Heterotopia (1) · Polymicrogyria (1) · Recurrence (1)
Brain Diseases (20) · Central Nervous System Diseases (20) · Epileptic Syndromes (20) · Nervous System Diseases (20) · Epilepsy, Generalized (19) · Epilepsy (18) · Pathological Conditions, Signs and Symptoms (5) · Neurologic Manifestations (3) · Signs and Symptoms (3) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (2) · Genetic Diseases, Inborn (2) · Pathologic Processes (2) · Congenital Abnormalities (1) · Disease Attributes (1) · Epilepsies, Partial (1)
Prednisolone (4) · Vigabatrin (3) · Cannabidiol (2) · ganaxolone (2) · Adrenocorticotropic Hormone (1) · Famotidine (1) · Fluorodeoxyglucose F18 (1) · Pyridoxine (1)
Lady Hardinge Medical College (3) · Jazz Pharmaceuticals (2) · Lundbeck LLC (2) · Marinus Pharmaceuticals (2) · All India Institute of Medical Sciences (1) · Hospices Civils de Lyon (1) · Johns Hopkins University (1) · National Institute of Neurological Disorders and Stroke (NINDS) (1) · Orphelia Pharma (1) · The Hospital for Sick Children (1) · University of California, Los Angeles (1) · University of California, San Francisco (1) · University of Colorado, Denver (1) · Wayne State University (1) · Yonsei University (1)
United States (10) · India (4) · Poland (2) · Argentina (1) · Australia (1) · Canada (1) · France (1)
Satinder Aneja, MD (2) · Carter Snead, MD (1) · Daniel Lowenstein, MD (1) · Eric Kossoff, MD (1) · Rama Chellappa, PhD (1) · Ruben Kuzniecky, MD (1) · Shaun A. Hussain, MD, MS (1) · Sheffali Gulati, MD (1) · Suvasini Sharma, MD, DM (1) · Tim Benke, MD (1)
PMID 21920781, PMID 25048310, PMID 29547159, PMID 32917807
2015 (2)