Takeda — Biomedical Watch V2

Traitements17programmes

Essais11liés

Publications6liées

SourceDBlocale

Traitements

17

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
DRALEGA — A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in SpainThe main aims of this study are to gather information about how many children, teenagers and adults in Spain have been diagnosed with Dravet syndrome and Lennox-Gastaut syndrome as well as to learn about the number of new Dravet syndrome and Lennox-Gastaut syndrome cases in persons in Spain. Participants' data will be taken from their medical records (charts), which were already collected as a part of their routine care in public hospitals in Spain between 01 January 2021 and 31 December 2022.	Épilepsie	À vérifier	Traitement symptomatique	Spain	À vérifier
DRALEGA-PT — A Study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in Children, Teenagers and Adults in PortugalThe main aim of this study is to learn about the percentage of persons diagnosed with Dravet Syndrome (DS) and Lennox-Gastaut-Syndrome (LGS) in 2022 and of persons newly diagnosed in 2021 and 2022 compared to the overall population in Portugal. Other aims are to understand how many percent of the persons diagnosed with DS and LGS are children, teenagers or adults and gather additional information on diagnosis and persons diagnosed with DS and LGS in Portugal. Information will be taken from a participant's existing medical hospital records. It is planned to review data in approximately 3 public hospitals in Portugal. No personal information of the participants will be collected.	Épilepsie	À vérifier	À vérifier		À vérifier
Leuprorelin (GC)The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids.	Cancer	Phase 2	À vérifier		À vérifier
Leuprorelin (GF)The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids.	Cancer	Phase 2	À vérifier		À vérifier
SoticlestatThe aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.	Épilepsie	Phase 3	À vérifier	United States, Australia, Belgium, Brazil, Canada, China, France, Germany, …	À vérifier
TAK-935The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.	Épilepsie	Phase 1/2	À vérifier	United States	À vérifier
Leuprorelin (GF)The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids.	Cancer	Phase 2	À vérifier		À vérifier
DRALEGA — A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in SpainThe main aims of this study are to gather information about how many children, teenagers and adults in Spain have been diagnosed with Dravet syndrome and Lennox-Gastaut syndrome as well as to learn about the number of new Dravet syndrome and Lennox-Gastaut syndrome cases in persons in Spain. Participants' data will be taken from their medical records (charts), which were already collected as a part of their routine care in public hospitals in Spain between 01 January 2021 and 31 December 2022.	Épilepsie	À vérifier	Traitement symptomatique	Spain	À vérifier
DRALEGA-PT — A Study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in Children, Teenagers and Adults in PortugalThe main aim of this study is to learn about the percentage of persons diagnosed with Dravet Syndrome (DS) and Lennox-Gastaut-Syndrome (LGS) in 2022 and of persons newly diagnosed in 2021 and 2022 compared to the overall population in Portugal. Other aims are to understand how many percent of the persons diagnosed with DS and LGS are children, teenagers or adults and gather additional information on diagnosis and persons diagnosed with DS and LGS in Portugal. Information will be taken from a participant's existing medical hospital records. It is planned to review data in approximately 3 public hospitals in Portugal. No personal information of the participants will be collected.	Épilepsie	À vérifier	À vérifier		À vérifier
SoticlestatThe aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.	Épilepsie	Phase 3	À vérifier	United States, Australia, Belgium, Canada, China, France, Germany, Greece, Hungary, Italy, Japan, Latvia, Netherlands, Poland, Russia, Serbia, Spain, Ukraine	À vérifier
SoticlestatThe aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.	Épilepsie	Phase 2	À vérifier	United States	À vérifier
SoticlestatThe aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.	Épilepsie	Phase 3	À vérifier	United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, Hungary, Italy, Japan, Latvia, Mexico, Netherlands, Poland, Russia, Serbia, Spain, Ukraine	À vérifier
SoticlestatThe aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.	Épilepsie	Phase 3	À vérifier	Denmark	À vérifier
SoticlestatThe aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.	Épilepsie	Phase 2	À vérifier	United States, Australia, Canada, China, Israel, Poland, Portugal, Spain	À vérifier
SoticlestatThe aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.	Épilepsie	Phase 3	À vérifier	United States, Australia, Brazil, Canada, China, France, Germany, Greece, Hungary, Italy, Japan, Latvia, Netherlands, Poland, Russia, Serbia, Spain, Ukraine	À vérifier
TAK-935The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.	Épilepsie	Phase 2	À vérifier	United States, Australia, Canada, China, Israel, Poland, Portugal, Spain	À vérifier
TAK-935The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.	Épilepsie	Phase 1/2	À vérifier	United States	À vérifier

Essais cliniques

11

Molécule	Indication / population	Phase	NCT	Titre	Statut
TAK-935	Épilepsie	Phase 1/2	NCT03166215	Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies	COMPLETED
TAK-935	Épilepsie	Phase 2	NCT03650452	ELEKTRA — A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies	COMPLETED
Soticlestat	Épilepsie	Phase 3	NCT04940624	A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome	COMPLETED
Soticlestat	Épilepsie	Phase 2	NCT03635073	Endymion 1 — A Study of Soticlestat in Adults and Children With Rare Epilepsies	TERMINATED
Soticlestat	Épilepsie	Phase 3	NCT06422377	A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine	TERMINATED
Soticlestat	Épilepsie	Phase 3	NCT05163314	A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome	TERMINATED
Soticlestat	Épilepsie	Phase 2	NCT03694275	A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)	COMPLETED
Soticlestat	Épilepsie	Phase 3	NCT04938427	A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome	COMPLETED
DRALEGA-PT — A Study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in Children, Teenagers and Adults in Portugal	Épilepsie	À vérifier	NCT06395792	DRALEGA-PT — A Study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in Children, Teenagers and Adults in Portugal	WITHDRAWN
DRALEGA — A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in Spain	Épilepsie	À vérifier	NCT05982717	DRALEGA — A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in Spain	COMPLETED
Leuprorelin (GF)	Cancer	Phase 2	NCT00776074	A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.	COMPLETED

Publications

6

Molécule	Indication / population	Titre	Journal	Date
Soticlestat		Antiseizure Medications in Development: Novel Mechanisms, Precision Therapy, and the Move Towards Disease Modification.	Current issues in molecular biology
Soticlestat		Head-to-head comparison of [F]CHL2205 versus [F]T008 as PET radioligands to study brain cholesterol homeostasis in rodent models and nonhuman primates.	European journal of nuclear medicine and molecular imaging
Soticlestat		Exploring the caregiver journey through randomized controlled trials in dravet syndrome: insights from a cross-sectional survey.	Epilepsy & behavior : E&B
Leuprorelin (GC)		The Impact of Triptorelin on Hormone Levels in Human and Its Metabolite Confirmation Using Liquid Chromatography-Ion Trap/Time-of-Flight Mass Spectrometry (LC/MS-IT-TOF) and Liquid Chromatography-Orbitrap (LC-Orbitrap) for Doping Control Analysis.	Drug testing and analysis
Leuprorelin (GC)		Outcomes Following Minimally Invasive Surgery for Intracerebral Hemorrhage in the AHA Get With The Guidelines-Stroke Registry.	Stroke
Leuprorelin (GF)		About a case of diffuse endometrial squamous metaplasia after resectoscopic myomectomy: a potential diagnostic pitfall for gynecologists and pathologists.	Applied immunohistochemistry & molecular morphology : AIMM