Institut de Recherches Internationales Servier — Biomedical Watch V2

Traitements5programmes

Essais1liés

Publications9liées

SourceDBlocale

Traitements

5

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
S230815- Dose BStudy 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.	Épilepsie	Phase 1/2	À vérifier	United States, France, Italy, Japan, Spain	À vérifier
S230815- Dose CStudy 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.	Épilepsie	Phase 1/2	À vérifier	United States, France, Italy, Japan, Spain	À vérifier
S230815- Dose DStudy 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.	Épilepsie	Phase 1/2	À vérifier	United States, France, Italy, Japan, Spain	À vérifier
S230815- Starting dose AStudy 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.	Épilepsie	Phase 1/2	À vérifier	United States, France, Italy, Japan, Spain	À vérifier
S230815- Starting dose AStudy 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.	Épilepsie	Phase 1/2	À vérifier	United States, France, Italy, Japan, Spain	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
S230815- Starting dose A	Épilepsie	Phase 1/2	NCT07227857	KANDLE — A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy	RECRUITING

Publications

9

Molécule	Indication / population	Titre	Journal	Date
S230815- Dose D		Trehalose: a potent enhancer of antioxidant responses in L. under arsenic toxicity.	Plant signaling & behavior
S230815- Dose D		Dose-response association between perinatal 25(OH)D status and postpartum depression.	Journal of psychosomatic obstetrics and gynaecology
S230815- Dose C		Efficacy of guided and unguided web-assisted self-help for parents of children with attention-deficit/hyperactivity disorder and oppositional defiant disorder: A three-arm randomized controlled trial.	Journal of child psychology and psychiatry, and allied disciplines
S230815- Dose C		Adaptive stepped care in preschool-age children with ADHD symptoms: a multicentre study including two consecutive randomised controlled trials (ESCApreschool).	European child & adolescent psychiatry
S230815- Dose C		Efficacy of a stepped-care approach for school-age children with mild to moderate ADHD (ESCAschool-moderate): an adaptive intervention study including a randomized controlled trial.	Child and adolescent psychiatry and mental health
S230815- Dose B		TimeTeller for timing health: The potential of circadian medicine to improve performance, prevent disease and optimize treatment.	Frontiers in digital health
S230815- Dose B		Analysis of Rhizonin Biosynthesis Reveals Origin of Pharmacophoric Furylalanine Moieties in Diverse Cyclopeptides.	Angewandte Chemie (International ed. in English)
S230815- Dose B		Bacterial Isothiocyanate Biosynthesis by Rhodanese-Catalyzed Sulfur Transfer onto Isonitriles.	Chembiochem : a European journal of chemical biology
S230815- Starting dose A		Randomized trial of dietician counseling to try to prevent weight gain associated with breast cancer adjuvant chemotherapy.	Oncology