Condition: Epileptic Encephalopathy · Sponsor: Institut de Recherches Internationales Servier
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.
This description comes directly from the study's public registry record.
Institut de Recherches Internationales Servier · +33 1 55 72 60-00 · scientificinformation@servier.com
Always discuss trial participation with your own doctor first.
| Children's Hospital of Orange County | Orange, California, United States | Not Yet Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | Recruiting |
| University of Rochester Medical Center | Rochester, New York, United States | Not Yet Recruiting |
| Nationwide Children's Hospital | Columbus, Ohio, United States | Not Yet Recruiting |
| The Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States | Not Yet Recruiting |
| Children's Health Dallas | Dallas, Texas, United States | Not Yet Recruiting |
| Institut Des Neurosciences De La Timone | Marseille, France | Recruiting |
| Hopital Necker Enfants Malades | Paris, France | Recruiting |
| Robert Debre University Hospital | Paris, France | Recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS | Florence, Italy | Not Yet Recruiting |
| Ospedale Pediatrico Bambino Gesu | Roma, Italy | Not Yet Recruiting |
| Shinshu University Hospital | Nagano, Japan | Recruiting |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07227857