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A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy
NCT07227857 · View on ClinicalTrials.gov ↗
Study Summary
Study CL1-230815-001 (KANDLE) is a Phase Ib/II, First In Human, multicentre, open-label, multiple ascending dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effect of S230815 in pediatric participants with KCNT1-related Developmental Epileptic Encephalopathy. To participate in the study, participants must have a diagnosis of Developmental Epileptic Encephalopathy due to a documented pathogenic or likely pathogenic variant in KCNT1 (to be confirmed by central genetic testing at the screening visit). The study consists of a screening period followed by two consecutive interventional parts. Part 1 will evaluate multiple ascending doses of S230815. Part 2 is a long-term treatment extension for participants who have completed Part 1. Participants will seamlessly roll-over from Part 1 to Part 2, resuming the same cohort as they were assigned in Part 1, and will receive S230815 for a maximum of 72 weeks.
Conditions Studied
Interventions
- DRUG S230815- Starting dose A
- DRUG S230815- Dose B
- DRUG S230815- Dose C
- DRUG S230815- Dose D
Study Locations (16)
Other
- Institut Des Neurosciences De La Timone — Marseille
- Hopital Necker Enfants Malades — Paris
- Robert Debre University Hospital — Paris
- Azienda Ospedaliera Universitaria Meyer IRCCS — Florence
- Ospedale Pediatrico Bambino Gesu — Roma
- Shinshu University Hospital — Nagano
- Osaka City General Hospital — Osaka
- Shizuoka Institute of Epilepsy and Neurological Disorders — Shizuoka
- Hospital Sant Joan De Deu Barcelona — Esplugues de Llobregat
- Hospital Ruber Internacional — Madrid
California
- Children's Hospital of Orange County — Orange
Massachusetts
- Boston Children's Hospital — Boston
New York
- University of Rochester Medical Center — Rochester
Ohio
- Nationwide Children's Hospital — Columbus
Pennsylvania
- The Children's Hospital of Philadelphia — Philadelphia
Texas
- Children's Health Dallas — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-11-24 |
| Est. Completion | 2028-04-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07227857
The ClinicalTrials.gov registry entry for NCT07227857 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Epileptic Encephalopathy appearing as the primary indexed condition, and to 4 interventions — of which S230815- Starting dose A is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07227857 reports 16 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07227857 about?
NCT07227857 is a clinical study titled "A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy". Study CL1-230815-001 (KANDLE) is a Phase Ib/II, First In Human, multicentre, open-label, multiple ascending dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effect of S230815 in pediatric participants with KCNT1-related Developmental Epileptic Encephalopa...
What is the current status of trial NCT07227857?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-11-24. Estimated completion is 2028-04-15.
What conditions does trial NCT07227857 study?
This clinical trial studies the following conditions: Epileptic Encephalopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07227857?
The interventions under investigation include: S230815- Starting dose A (DRUG), S230815- Dose B (DRUG), S230815- Dose C (DRUG), S230815- Dose D (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07227857?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07227857 being conducted?
This trial has 16 study locations across California, Massachusetts, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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