University Hospital Tuebingen — Biomedical Watch V2

Traitements9programmes

Essais7liés

Publications8liées

SourceDBlocale

Traitements

9

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Pathophysiology Based Therapy of Early Onset Epileptic EncephalopathiesGenetic epileptic encephalopathies (EEs) are a group of very rare and severe, pharmaco-resistant epilepsy forms characterized by an early onset, e.g. first years of life, and an often severe developmental delay. Genetic defects were found in different ion channels such as potassium or sodium channels explaining well the pathological neuronal hyperexcitability leading to seizures. Further mutations were also found in proteins relevant for cell structure, DNA/RNA processing or the synaptic vesicular metabolism. Specific and individualized therapies have not been established neither in the clinical routine nor in controlled studies. The goal of this monocentric non-blinded non-placebo controlled phase IIb study is the evaluation of the effectivity of anticonvulsive drugs specifically working on the ion channels defective in some subtypes of EEs in order to establish a standard and individualized therapy for these rare diseases based on the specific genetic defect.	Épilepsie	Phase 2	À vérifier	Germany	À vérifier
PrasinezumabThe purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.	Parkinson	Phase 2	Traitement symptomatique	France, Germany, Italy, Luxembourg, Spain, Sweden, United Kingdom	À vérifier
Sodium ChlorideThis is a proof-of-concept trial to investigate the efficacy of prasinezumab to slow or prevent cognitive decline in people with Parkinson's disease carrying a severe mutation in the GBA (glucocerebrosidase) gene. The duration of the intervention per patient will be 104 weeks with monthly infusions. The investigators plan to enroll 120 participants (60 participants per treatment arm). This study will be conducted across Europe in the following countries: France, Germany, Italy, Luxembourg, Spain, Sweden, UK.	Parkinson	Phase 2	Traitement symptomatique	France, Germany, Italy, Luxembourg, Spain, Sweden, United Kingdom	À vérifier
Vaccines, PeptideThe aim of this Phase I study is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.	Cancer	Phase 1	À vérifier	Germany	À vérifier
Pathophysiology Based Therapy of Early Onset Epileptic EncephalopathiesGenetic epileptic encephalopathies (EEs) are a group of very rare and severe, pharmaco-resistant epilepsy forms characterized by an early onset, e.g. first years of life, and an often severe developmental delay. Genetic defects were found in different ion channels such as potassium or sodium channels explaining well the pathological neuronal hyperexcitability leading to seizures. Further mutations were also found in proteins relevant for cell structure, DNA/RNA processing or the synaptic vesicular metabolism. Specific and individualized therapies have not been established neither in the clinical routine nor in controlled studies. The goal of this monocentric non-blinded non-placebo controlled phase IIb study is the evaluation of the effectivity of anticonvulsive drugs specifically working on the ion channels defective in some subtypes of EEs in order to establish a standard and individualized therapy for these rare diseases based on the specific genetic defect.	Épilepsie	Phase 2	À vérifier	Germany	À vérifier
PrasinezumabThe purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.	Parkinson	Phase 3	Traitement symptomatique	United States, Australia, Austria, Brazil, Canada, China, Denmark, France, Germany, Italy, Mexico, Poland, Portugal, South Korea, Spain, Taiwan, United Kingdom	À vérifier
PrasinezumabThe purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.	Parkinson	Phase 2	Traitement symptomatique	United States, Austria, Canada, France, Italy, Luxembourg, Poland, Spain, United Kingdom	À vérifier
PrasinezumabThe purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.	Parkinson	Phase 2	Traitement symptomatique	France, Germany, Italy, Luxembourg, Spain, Sweden, United Kingdom	À vérifier
Vaccines, PeptideThe aim of this Phase I study is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.	Cancer	Phase 1	À vérifier	Germany	À vérifier

Essais cliniques

7

Molécule	Indication / population	Phase	NCT	Titre	Statut
Vaccines, Peptide	Cancer	Phase 1	NCT06252584	AML-VAC-XS15 — Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia Patients	RECRUITING
Prasinezumab	Parkinson	Phase 2	NCT07055087	PreCoDe — Prevent Cognitive Decline in GBA-associated Parkinson's Disease	RECRUITING
Prasinezumab	Parkinson	Phase 2	NCT04777331	PADOVA — A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease	ACTIVE_NOT_RECRUITING
Prasinezumab	Parkinson	Phase 3	NCT07174310	PARAISO — A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease	RECRUITING
transcutaneous vagus nerve stimulation	SEP	Non applicable	NCT05120336	tVNS Effects on Motivation in Depression	COMPLETED
levetiracetam	Épilepsie	Phase 4	NCT00571155	Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery	COMPLETED
Pathophysiology Based Therapy of Early Onset Epileptic Encephalopathies	Épilepsie	Phase 2	NCT02968966	Pathophysiology Based Therapy of Early Onset Epileptic Encephalopathies	WITHDRAWN

Publications

8

Molécule	Indication / population	Titre	Journal	Date
Prasinezumab		Progress of Immunotherapies in Parkinson's Disease.	CNS neuroscience & therapeutics
Prasinezumab		The conundrum of alpha-synuclein antibody failures in Parkinson's disease: a narrative review of mechanisms and alternative metabolic hypotheses.	Therapeutic advances in neurological disorders
Prasinezumab		The Efficacy and Safety of Monoclonal Antibodies That Target Alpha-Synuclein in Parkinson's Disease: A Systematic Review.	Parkinson's disease
Pathophysiology Based Therapy of Early Onset Epileptic Encephalopathies		SLC6A1-Related Neurodevelopmental Disorder: A Scoping Review of Clinical Features and Emerging Therapeutic Strategies.	Pediatric neurology
Pathophysiology Based Therapy of Early Onset Epileptic Encephalopathies		The clinical utility of interictal multi-channel short-duration bursts: A supplemental biomarker for epileptogenic zone localization.	Epilepsy research
Pathophysiology Based Therapy of Early Onset Epileptic Encephalopathies		SYNGAP1-related disorder: pathophysiology, epilepsy, cognitive and behavioral phenotypes, and precision therapeutic approaches.	Epilepsy & behavior : E&B
Pathophysiology Based Therapy of Early Onset Epileptic Encephalopathies		Anti-Seizure Medications Alter Functional and Effective Connectivity as Measured With Intracranial Electroencephalography.	Brain and behavior
Pathophysiology Based Therapy of Early Onset Epileptic Encephalopathies		Effects of Pregestational Stress and Concomitant Administration of Dracocephalum moldavica Extract on Seizure Behaviours in Next Generation Developing Rats.	International journal of developmental neuroscience : the official journal of the International Society for Developmental Neuroscience