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NCT07227857 · ClinicalTrials.gov registry record · Phase 1
A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy
A Phase 1 study of Epileptic Encephalopathy, sponsored by Institut de Recherches Internationales Servier.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 16
- Study locations
NCT07227857: Recruiting Phase 1 study of Epileptic Encephalopathy, sponsored by Institut de Recherches Internationales Servier.
NCT07227857 is a Phase 1 study of Epileptic Encephalopathy that is actively recruiting participants, run by Institut de Recherches Internationales Servier. The registered enrollment target is 20 participants, below the 1,821-participant average among 3 other Epileptic Encephalopathy trials with a reported enrollment target (99% lower). The trial reports 16 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07227857, a Phase 1 study of Epileptic Encephalopathy, is actively recruiting participants, sponsored by Institut de Recherches Internationales Servier.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 16
- Study locations
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 |
What NCT07227857 shows while recruiting
NCT07227857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,821-participant average among 3 other Epileptic Encephalopathy trials with a reported enrollment target (99% lower).
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.
NCT07227857 lists 16 locations in 7 states (Other, California, Massachusetts).
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.
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).
Who is sponsoring clinical trial NCT07227857?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
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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