Spasms, Infantile clinical trials
The registry lists 47 studies for Spasms, Infantile across more than 10 countries. 8 are recruiting or about to start. 41 of them are mainly about Spasms, Infantile (how this is decided). Per ClinicalTrials.gov, last updated 2026-10-14.
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Who runs them
Lady Hardinge Medical College (5) · Jazz Pharmaceuticals (3) · All India Institute of Medical Sciences, New Delhi (3) · University of Colorado, Denver (3) · Assistance Publique - Hôpitaux de Paris (2) · Lundbeck LLC (2) · Marinus Pharmaceuticals (2) · National Center for Research Resources (NCRR) (1)
What is being tested here
Drugs under test in Spasms, Infantile studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Prednisolone | 2 | 3 | 5 |
| Vigabatrin | 1 | 0 | 3 |
| Adrenocorticotropic Hormone | 1 | 1 | 3 |
| Fenfluramine | 1 | 1 | 2 |
| Famotidine | 1 | 0 | 1 |
| Steroids | 1 | 1 | 1 |
| Cannabidiol | 0 | 4 | 5 |
| Ganaxolone | 0 | 0 | 2 |
| Soticlestat | 0 | 0 | 1 |
| Tricaprylin | 0 | 0 | 1 |
Drug classes tested here Corticosteroids 2 open
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
All 2, phase 3 first
- Nov 2027A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder. · Phase 3 · Zogenix, Inc.
- Dec 2026Treatment of Refractory Infantile Spasms With Fenfluramine · Children's Hospital of Orange County
Who these studies take
Of the 7 Spasms, Infantile studies recruiting now, 0 (0%) set no upper age limit and 7 (100%) stop at 75 or younger. 7 (100%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 0 (0%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 1 (14%) | 1 (14%) |
| 18 | 0 (0%) | 0 (0%) |
| 30 | 0 (0%) | 0 (0%) |
| 40 | 0 (0%) | 0 (0%) |
| 50 | 0 (0%) | 0 (0%) |
| 65 | 0 (0%) | 0 (0%) |
| 75 | 0 (0%) | 0 (0%) |
| 85 | 0 (0%) | 0 (0%) |
Across all 47 studies, recruiting or not: 94% stop at 75 or younger and 94% at 65; 100% take children; 0% are for women only and 0% for men only; 2% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
What changed recently
From the registry's own updates since Oct 13, 2026.
Stopped1
- Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic EpilepsiesTerminatedOct 14, 2026NCT06700811
Studies
Recruiting first, then most recently updated. Showing 47 of 47. search them.
- IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).Not yet recruitingNCT075856432 countries
- Treatment of Refractory Infantile Spasms With FenfluramineRecruitingNCT04289467Phase 21 country
- Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and AdolescentsRecruitingNCT051269141 country
- A Study to Prevent Infantile Spasms RelapseRecruitingNCT06819670Phase 21 country
- Characterization by Automated System on Infantile SpasmesRecruitingNCT062662341 country
- Cortical Excitability in West Syndrome Using Transcranial Magnetic StimulationRecruitingNCT06201897Phase 2/31 country
- Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label StudyRecruitingNCT05958160Phase 2/31 country
- Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile SpasmRecruitingNCT04302116Not applicable1 country
- Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic EpilepsiesTerminatedNCT06700811Phase 11 country
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic EncephalopathiesCompletedNCT03650452Phase 28 countries
- Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)TerminatedNCT01367964Not applicable1 country
- Artificial Intelligence-based Video Analysis to Detect Infantile SpasmsCompletedNCT063158291 country
- A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.Active, not recruitingNCT05064878Phase 314 countries
- The Effect of Spa and Massage on Babies on Colic SymptomsCompletedNCT05538936Not applicable1 country
- 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 SeizuresTerminatedNCT04485104Phase 33 countries
- 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)Active, not recruitingNCT06838559Phase 41 country
- Tricaprilin Infantile Spasms Pilot StudyCompletedNCT04727970Phase 12 countries
- A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms PatientsTerminatedNCT03976076Phase 22 countries
- Ketogenic Diet vs ACTH for the Treatment of Children With West SyndromeActive, not recruitingNCT05279118Phase 2/31 country
- Open-label Extension to Protocol 1042-0500TerminatedNCT00442104Phase 21 country
- A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile SpasmsTerminatedNCT03421496Phase 31 country
- A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile SpasmsCompletedNCT00441896Phase 21 country
- Cannabidiol in Children With Refractory Epileptic EncephalopathyStatus unknownNCT03024827Phase 11 country
- A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile SpasmsWithdrawnNCT05128344Phase 38 countries
- Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)CompletedNCT02953548Phase 32 countries
- Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)CompletedNCT02954887Phase 32 countries
- Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine TechnologyStatus unknownNCT04086992Not applicable1 country
- Genetic Studies in Patients and Families With Infantile SpasmsCompletedNCT017237871 country
- A Novel Approach to Infantile SpasmsSuspendedNCT03347526Phase 31 country
- Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile SpasmsStatus unknownNCT03876444Phase 2/31 country
- Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile SpasmsWithdrawnNCT02299115Phase 31 country
- A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)TerminatedNCT02829827Phase 21 country
- Evaluation of the Modified Atkins Diet in Children With Epileptic SpasmsStatus unknownNCT03807141Phase 2/31 country
- Addition of Pyridoxine to Prednisolone in Infantile SpasmsCompletedNCT01828437Phase 31 country
- Epilepsy Phenome/Genome ProjectCompletedNCT005520453 countries
- Cannabidiol Oral Solution for Treatment of Refractory Infantile SpasmsTerminatedNCT02551731Phase 21 country
- Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial EpilepsyCompletedNCT02220114Not applicable1 country
- Evaluation of Neuroinflammation in Children With Infantile SpasmsCompletedNCT02092883Phase 41 country
- Molecular Genetics in Infantile SpasmsCompletedNCT02885389
- Sabril Patient RegistryCompletedNCT01073579
- Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal TherapyWithdrawnNCT01549288Phase 2/31 country
- Prednisolone in Infantile Spasms- High Dose Versus Usual DoseCompletedNCT01575639Phase 31 country
- An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile SpasmsWithdrawnNCT01413711Phase 4
- Use of the Modified Atkins Diet in Infantile SpasmsCompletedNCT01006811Phase 2/31 country
- Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled StudyCompletedNCT00968136
- Metabolic Abnormalities in Children With EpilepsyCompletedNCT000013251 country
- Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard TreatmentCompletedNCT00004758Phase 2