3 recruiting, 2 completed, 2 unknown, 1 not yet recruiting. 4 Phase 3, 3 Phase 2, 2 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Unknown 2, Suspended 1, Terminated 1 |
| Phase 2 | 3 | Unknown 2, Recruiting 1 |
| Not applicable | 2 | Completed 1, Recruiting 1 |
| Phase 1 | 1 | Completed 1 |
Follow Infantile Spasm: new trials by email Literature Review of Infantile Spasm trials Research Report on Infantile Spasm
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 | |
| Characterization by Automated System on Infantile Spasmes Infantile Spasm | Recruiting | Assistance Publique - Hôpitaux de Paris | 5000 | 2024-02-01 | 2025-02-11 | |
| 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 |
| 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 |
| Tricaprilin Infantile Spasms Pilot Study Tricaprilin - Infantile Spasm | Phase 1 | Completed | Cerecin | 8 | 2021-11-01 | 2024-09-19 |
| 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 |
| 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 |
| A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms Cannabidiol Oral Solution, Placebo, Vigabatrin - Infantile Spasm | Phase 3 | Terminated | Radius Pharmaceuticals, Inc. | 2 | 2018-09-05 | 2023-06-07 |
| A Novel Approach to Infantile Spasms Cosyntropin Injectable Suspension, 1 mg/mL, Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin, Vigabatrin - Infantile Spasm | Phase 3 | Suspended | University of Colorado, Denver | 394 | 2018-04-19 | 2021-05-27 |
Spasms, Infantile (10) · Colic (1) · Epilepsy (1) · Infantile Epileptic-Dyskinetic Encephalopathy (1) · Nervous System Diseases (1)
Brain Diseases (10) · Central Nervous System Diseases (10) · Epilepsy, Generalized (10) · Epileptic Syndromes (10) · Epilepsy (9) · Nervous System Diseases (9) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1) · Infant, Newborn, Diseases (1)
Vigabatrin (3) · Adrenocorticotropic Hormone (1) · Cannabidiol (1) · Combined Modality Therapy (1) · Diet Therapy (1) · Diet, Ketogenic (1) · Fenfluramine (1) · Hydrotherapy (1) · Massage (1) · Prednisolone (1) · Therapeutic Touch (1) · tricaprylin (1)
All India Institute of Medical Sciences (1) · Assistance Publique - Hôpitaux de Paris (1) · Cerecin (1) · Children's Hospital of Orange County (1) · Kullasate Sakpichaisakul (1) · Radius Pharmaceuticals, Inc. (1) · Suvasini Sharma (1) · Telethon Kids Institute (1) · University of Colorado, Denver (1) · Yuzuncu Yil University (1)
United States (3) · Australia (2) · India (2) · Brazil (1) · France (1) · Singapore (1) · Thailand (1) · Turkey (Türkiye) (1)
Daniel Shrey, MD (1) · Dipti Kapoor, MD (1) · Jean Bergounioux, MD, PhD (1) · Kelly G. Knupp, MD (1) · Kullasate Sakpichaisakul, MD (1) · Samuel Diop, PhD (1) · Sheffali Gulati (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 22689735, PMID 22859699, PMID 24657009, PMID 26216500, PMID 26280806, PMID 26302697, PMID 27838190, PMID 29105055, PMID 29966811, PMID 33575989, PMID 40116235, PMID 40253272, PMID 4515986, PMID 6308515, PMID 6539199, PMID 8604274, PMID 8681895