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A neonatal/infantile epilepsy syndrome where seizures start in the neonate between day 4 and 7 of life and are often unilateral clonic events that recur and may alternate sides from seizure to seizure. Seizures can be repetitive over hours to days. Seizures remit by 4-6 months of age. A proportion of those affected may have seizures in later life. The child is expected to have normal developmental progress. This is distinguished from familial neonatal epilepsy on the basis of family history. These entities may have similar genetic etiologies, with de novo mutations responsible for the lack of family history in self-limited neonatal seizures.
1 FDA-approved treatment is available for self-limited neonatal seizures, including PHENOBARBITAL SODIUM (SEZABY, approved 2022). An additional 2 compounds hold orphan drug designation.
Brand Name | Generic Name | Mechanism | Approved | Market Status |
|---|---|---|---|---|
No clinical trials have been registered for self-limited neonatal seizures.
31 publications have been identified in PubMed for self-limited neonatal seizures. Research spans Case Report / Case Series (33%), Epidemiology / Natural History (33%), and Basic Science / Preclinical (17%).
Research Type | Count | % of Total |
|---|---|---|
Patient case studies | 10 | 33% |
Data assembled from 3 of 12 sources · Last updated Sep 19, 2026, 4:36 PM UTC
SEZABY |
PHENOBARBITAL SODIUM |
— |
2022 |
Available |
The following drugs have received orphan drug designation from the FDA for self-limited neonatal seizures. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|---|---|---|---|---|
topiramate | topiramate | PrevEP Inc. | 2024 | — | Designated |
levetiracetam | levetiracetam | University of California | 2010 | — | Designated |
Gene therapy approaches for self-limited neonatal seizures have been reported in the published literature.
View trials for self-limited neonatal seizures
Disease patterns and progression
10 |
33% |
Laboratory research | 5 | 17% |
Research summaries | 2 | 7% |
Clinical study results | 2 | 7% |
New treatment approaches | 1 | 3% |
Hassan WM (2026). [PMID: 42112227](https://pubmed.ncbi.nlm.nih.gov/42112227/). *Infect Drug Resist*. [Case Report / Case Series]
Lacey AS (2026). [PMID: 41352324](https://pubmed.ncbi.nlm.nih.gov/41352324/). *Seizure*. [Epidemiology / Natural History]
Vikin T (2026). [PMID: 41066145](https://pubmed.ncbi.nlm.nih.gov/41066145/). *Epilepsia*. [Epidemiology / Natural History]
Thompson EC (2026). [PMID: 41670008](https://pubmed.ncbi.nlm.nih.gov/41670008/). *J Biomol Struct Dyn*. [Basic Science / Preclinical]
Nishijo T (2026). [PMID: 41742307](https://pubmed.ncbi.nlm.nih.gov/41742307/). *Acta Neuropathol Commun*. [Basic Science / Preclinical]
Al Rawahi S (2026). [PMID: 42017391](https://pubmed.ncbi.nlm.nih.gov/42017391/). *Epileptic Disord*. [Review / Meta-Analysis]
Balasundaram P (2026). [PMID: 34033328](https://pubmed.ncbi.nlm.nih.gov/34033328/). *Unknown Journal*. [Case Report / Case Series]
Mangano GD (2026). [PMID: 42024975](https://pubmed.ncbi.nlm.nih.gov/42024975/). *Seizure*. [Basic Science / Preclinical]
Oliveira-Madureira T (2026). [PMID: 41632366](https://pubmed.ncbi.nlm.nih.gov/41632366/). *Biochem Genet*. [Basic Science / Preclinical]
Xiong J (2026). [PMID: 41579097](https://pubmed.ncbi.nlm.nih.gov/41579097/). *Epilepsia*. [Case Report / Case Series]