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Disease

Infantile spasms

Late-stage therapeutic development
Also known as IESS, West syndrome, West's syndrome, infantile epileptic spasms syndrome+5 more

IESS, West syndrome, West's syndrome, infantile epileptic spasms syndrome, infantile spasms syndrome, intellectual disability-hypsarrhythmia syndrome, X-linked infantile spasm syndrome, X-linked infantile spasms, tonic spasms with clustering, arrest of psychomotor development and hypsarrhythmia on EEG.

12
Clinical trials
12
Associated genes
4
Related proteins

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

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Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Vigabatrinapproved

Approval — Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for… (2018)

Clinical trials

10 sponsors · 0 new · 0 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme
12
All trials
1
Active
6
Late-stage
6
Completed
Late-stage studies

A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study

Phase 3 · Completed · Jazz Pharmaceuticals

Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH

Phase 4 · Completed · Wayne State University

Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial

Phase 3 · Completed · Lady Hardinge Medical College

Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.

Phase 3 · Completed · Lady Hardinge Medical College

Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms

Phase 3 · Withdrawn · The Hospital for Sick Children

An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms

Phase 4 · Withdrawn · Lundbeck LLC
Recruiting

A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse

Phase 2 · Recruiting · University of California, Los Angeles
Recently completed

A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study

Phase 3 · Completed · Jazz Pharmaceuticals

Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized Study

N/A · Completed · Orphelia Pharma

Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH

Phase 4 · Completed · Wayne State University

Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial

Phase 3 · Completed · Lady Hardinge Medical College

Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.

Phase 3 · Completed · Lady Hardinge Medical College

A Double-blind, Placebo-controlled, Dose-ranging Clinical Study to Evaluate the Safety, Tolerability, and Antiepileptic Activity of Ganaxolone in Treatment of Patients With Infantile Spasms

Phase 2 · Completed · Marinus Pharmaceuticals

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2018emaApproval — Vigabatrin· Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: Treatment in monotherapy of infantile spasms (West's syndrome). Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

ST3GAL30.71SPTAN10.65SCN2A0.65GRIN2B0.61CDKL50.58ABAT0.57GUF10.53MC2R0.48GNPDA20.43KCNC20.39NTRK20.38PLCB10.38

Disease biology

4 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Sodium channel protein type 2 subunit alphavia SCN2A0.65Glutamate receptor ionotropic, NMDA 2Bvia GRIN2B0.61Voltage-gated potassium channel KCNC2via KCNC20.39BDNF/NT-3 growth factors receptorvia NTRK20.38

Reference

Authoritative identity, definition & identifiers.

Synonyms

IESS, West syndrome, West's syndrome, infantile epileptic spasms syndrome, infantile spasms syndrome, intellectual disability-hypsarrhythmia syndrome, X-linked infantile spasm syndrome, X-linked infantile spasms, tonic spasms with clustering, arrest of psychomotor development and hypsarrhythmia on EEG

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.