19 completed, 8 terminated, 7 unknown, 5 recruiting. 17 Phase 3, 16 Phase 2, 5 Not applicable, 3 Phase 1, 3 Phase 4.
Follow Spasms, Infantile: new trials by email Literature Review of Spasms, Infantile trials Research Report on Spasms, Infantile
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 |
|---|---|---|---|---|---|---|
| IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE). Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors. - Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy | Not yet recruiting | Telethon Kids Institute | 40 | 2026-09-03 | 2026-07-17 | |
| Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents Epilepsy, West Syndrome | Recruiting | Assistance Publique - Hôpitaux de Paris | 1000 | 2025-12-11 | 2026-02-24 | |
| Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies Ketogenic diet - Developmental and Epileptic Encephalopathies, Epileptic Spasms | Phase 1 | Terminated | Heather Olson | 1 | 2025-08-11 | 2026-10-14 |
| 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 |
| Clinical Trial on 7-day Followed by Maintenance Therapy for 10 Weeks vs. 14-day and no Maintenance Course of Prednisolone for the Treatment of Infantile Epileptic Spasms Syndrome (IESS) Short-Duration Oral Prednisolone with Extended Tapering, Standard Oral Prednisolone Regimen with Tapering - Spasms, Infantile, Prednisolone | Phase 4 | Active not recruiting | University of Colombo | 182 | 2025-01-01 | 2025-02-24 |
| Artificial Intelligence-based Video Analysis to Detect Infantile Spasms Spasm Vision - Infantile Spasms | Completed | Johns Hopkins University | 61 | 2024-08-26 | 2026-05-07 | |
| Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation ACTH/Oral Steroids - West Syndrome | Phase 2 / Phase 3 | Unknown | All India Institute of Medical Sciences | 40 | 2024-03-01 | 2024-03-04 |
| Characterization by Automated System on Infantile Spasmes Infantile Spasm | Recruiting | Assistance Publique - Hôpitaux de Paris | 5000 | 2024-02-01 | 2025-02-11 | |
| Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study Modified Atkins diet, Topiramate - Epileptic Spasms, Failed Hormonal Therapy | Phase 2 / Phase 3 | Unknown | Lady Hardinge Medical College | 70 | 2023-07-20 | 2023-07-24 |
| Treatment of Refractory Infantile Spasms With Fenfluramine Fenfluramine - Infantile Spasm | Phase 2 | Recruiting | Children's Hospital of Orange County | 10 | 2023-06-16 | 2026-04-15 |
| A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms AMZ002 injectable solution, 0.5mg/mL, Vigabatrin, oral - Spasms, Infantile | Phase 3 | Withdrawn | Amzell | 2023-04-01 | 2023-04-20 | |
| The Effect of Spa and Massage on Babies on Colic Symptoms Baby SPA, Massage - Infantile Colic, Infantile Spasm | Not applicable | Completed | Yuzuncu Yil University | 72 | 2022-08-01 | 2025-12-18 |
| Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome Ketogenic diet, ACTH - Ketogenic Diet, West Syndrome | Phase 2 / Phase 3 | Unknown | All India Institute of Medical Sciences | 80 | 2022-04-18 | 2024-06-25 |
| 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 |
| Tricaprilin Infantile Spasms Pilot Study Tricaprilin - Infantile Spasm | Phase 1 | Completed | Cerecin | 8 | 2021-11-01 | 2024-09-19 |
| Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures GWP42003-P - Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome | Phase 3 | Terminated | Jazz Pharmaceuticals | 3 | 2021-05-19 | 2025-10-31 |
| Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm Combination therapy with vigabatrin and prednisolone, Vigabatrin Tablets - Infantile Spasm, West Syndrome | Not applicable | Recruiting | Kullasate Sakpichaisakul | 250 | 2020-05-18 | 2021-08-25 |
| A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients JBPOS0101 - Refractory Infantile Spasms | Phase 2 | Terminated | Bio-Pharm Solutions Co., Ltd. | 16 | 2020-04-15 | 2024-08-22 |
| Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology Remote monitoring - Infantile Spasms, Non-Intractable | Not applicable | Unknown | University of Colorado, Denver | 40 | 2019-10-10 | 2022-05-04 |
| Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms Intravenous Methylprednisolone, Oral Pednisolone - Infantile Spasm | Phase 2 / Phase 3 | Unknown | Suvasini Sharma | 128 | 2019-04-01 | 2019-11-18 |
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Epilepsy (9) · Seizures (9) · Lennox Gastaut Syndrome (5) · Epilepsies, Myoclonic (4) · CDKL5 deficiency disorder (2) · Central Nervous System Diseases (2) · Epilepsies, Partial (2) · Malformations of Cortical Development (2) · Nervous System Diseases (2) · Recurrence (2) · Tuberous Sclerosis (2) · Brain Diseases (1) · Colic (1) · Drug Resistant Epilepsy (1)
Brain Diseases (46) · Epilepsy, Generalized (46) · Epileptic Syndromes (46) · Central Nervous System Diseases (45) · Nervous System Diseases (45) · Epilepsy (38) · Pathological Conditions, Signs and Symptoms (13) · Signs and Symptoms (10) · Neurologic Manifestations (9) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (6) · Genetic Diseases, Inborn (5) · Pathologic Processes (4) · Congenital Abnormalities (3) · Disease Attributes (3) · Nervous System Malformations (3)
Vigabatrin (7) · Cannabidiol (5) · Prednisolone (5) · Adrenocorticotropic Hormone (3) · Diet, Ketogenic (3) · Fenfluramine (2) · Pyridoxine (2) · ganaxolone (2) · Carbamazepine (1) · Combined Modality Therapy (1) · Diet Therapy (1) · Famotidine (1) · Fluorodeoxyglucose F18 (1) · Hydrotherapy (1) · Massage (1)
Lady Hardinge Medical College (5) · All India Institute of Medical Sciences (3) · Jazz Pharmaceuticals (3) · University of Colorado, Denver (3) · Assistance Publique - Hôpitaux de Paris (2) · Lundbeck LLC (2) · Marinus Pharmaceuticals (2) · Amzell (1) · Ann & Robert H Lurie Children's Hospital of Chicago (1) · Bio-Pharm Solutions Co., Ltd. (1) · Cerecin (1) · Children's Hospital of Orange County (1) · Heather Olson (1) · Hospices Civils de Lyon (1) · INSYS Therapeutics Inc (1)
United States (22) · India (10) · France (5) · Australia (4) · Poland (4) · Spain (4) · Canada (3) · Italy (3) · Argentina (2) · Israel (2) · Portugal (2) · Austria (1) · Belgium (1) · Brazil (1) · China (1)
Satinder Aneja, MD (2) · Suvasini Sharma, MD, DM (2) · Carter Snead, MD (1) · Carukshi Arambepola, MSc, MD (1) · Daniel Lowenstein, MD (1) · Daniel Shrey, MD (1) · Dipti Kapoor, MD (1) · Doulgas R Nordli, Jr, MD (1) · Eric Kossoff, MD (1) · Hee Jin Kim (1) · Jane Alcorn, PhD (1) · Jean Bergounioux, MD, PhD (1)
PMID 10368073, PMID 10561962, PMID 10565592, PMID 11673582, PMID 12403260, PMID 14734931, PMID 15159460, PMID 15509243, PMID 15541450, PMID 18077226, PMID 20608959, PMID 21070215, PMID 21920781, PMID 22689735, PMID 22859699, PMID 24657009, PMID 25048310, PMID 26216500, PMID 26280806, PMID 26302697, PMID 27838190, PMID 29105055, PMID 29547159, PMID 29966811, PMID 31333569, PMID 32917807, PMID 33575989, PMID 33834913, PMID 35841234, PMID 40116235, PMID 40253272, PMID 40840039, PMID 4515986, PMID 6308515, PMID 6539199, PMID 8604274, PMID 8681895
2015 (2), 2016 (1), 2018 (1), 2023 (1)