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Epilepsies, Myoclonic clinical trials

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NCT ID: NCT06422377 Recruiting - Clinical trials for Dravet Syndrome (DS)

A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

Start date: April 25, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to check how soticlestat impacts symptoms of Dravet syndrome [DS] and Lennox-Gastaut syndrome [LGS] in participants who have been exposed to fenfluramine.

NCT ID: NCT06395792 Not yet recruiting - Clinical trials for Dravet Syndrome (DS)

A Study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in Children, Teenagers and Adults in Portugal

DRALEGA-PT
Start date: April 30, 2024
Phase:
Study type: Observational

The 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.

NCT ID: NCT06371794 Enrolling by invitation - Dravet Syndrome Clinical Trials

EXploring novEl Molecular Determinants of DRAvet Syndrome Phenotype Heterogeneity

EXEDRA
Start date: July 6, 2023
Phase: N/A
Study type: Interventional

Dravet syndrome is characterized as a developmental encephalopathy resulting from mutations of SCN1A, the gene encoding the alpha subunit of the voltage-gated sodium channel Nav1.1. The syndrome typically presents with drug-resistant epilepsy and varying degrees of cognitive disorders. Current treatment efficacy may be hindered by insufficient knowledge of undiscovered molecular determinants of the disease and its heterogeneous nature. Utilizing induced pluripotent stem cells (iPSCs) derived from skin biopsies, accessibility to patients' brain neurons has enabled successful modeling of various genetic neurological diseases. Neurons and brain organoids will be obtained from Dravet syndrome patients exhibiting diverse phenotypic severities, encompassing behavioral and developmental delays, to discern the molecular determinants of phenotypic diversity. Specifically, emphasis will be placed on investigating cellular and molecular mechanisms linking altered neuronal excitability with synaptic dysfunction.The study will focus on exploring the expression of newly identified modifiers potentially associated with neuronal excitability and synaptic function in iPSC-derived human neurons. This aims to establish correlations between the severity of epileptic and cognitive phenotypes and the altered expression of these proteins, whose functions are not fully understood.In the mid to long term, efforts will be directed towards overcoming the limitations of conventional therapeutic approaches for Dravet syndrome. This will involve attempting to reverse the observed morphological and functional alterations in Dravet syndrome neurons using viral vectors to promote overexpression/downregulation of identified modifiers correlated with disease severity. The anticipated outcomes of this project are expected to unveil novel molecular mechanisms underlying the pathophysiology of this severe neurogenetic disease, characterized by varying degrees of cognitive impairment. Moreover, these findings may pave the way for the discovery of innovative therapeutic strategies.

NCT ID: NCT06283212 Recruiting - Dravet Syndrome Clinical Trials

A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome

UK Only
Start date: April 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to < 48 months. The study follows and open-label, dose-escalation design.

NCT ID: NCT06153186 Terminated - Clinical trials for Childhood Absence Epilepsy

Flunarizine for Treatment Resistant Absence Epilepsy

Start date: September 20, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, single-centre study to evaluate the clinical efficacy, safety and tolerability of Flunarizine administered as adjunctive treatment in participants diagnosed with treatment resistant absence epilepsy. The study goal is to see how efficient and safe flunarizine is at decreasing the frequency of absence seizures in children with treatment-resistant refractory epilepsy at doses of 5mg and 10mg once daily.

NCT ID: NCT06149663 Available - Dravet Syndrome Clinical Trials

Intermediate-Size Expanded Access Protocol (EAP) for LP352

Start date: n/a
Phase:
Study type: Expanded Access

This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in patients with Developmental and Epileptic Encephalopathies (DEEs). The EAP study will allow continued treatment with LP352 for eligible patients diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation).

NCT ID: NCT06118255 Recruiting - Dravet Syndrome Clinical Trials

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

ORCHID
Start date: May 21, 2024
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.

NCT ID: NCT06112275 Recruiting - Dravet Syndrome Clinical Trials

A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome (Australia Only)

Start date: March 2024
Phase: Phase 1/Phase 2
Study type: Interventional

WAYFINDER is a Phase 1/2 study in Australia to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged 36 to <84 months (3 to <7 years). The study follows an open-label, dose-escalation design.

NCT ID: NCT05982717 Recruiting - Clinical trials for Dravet Syndrome (DS)

A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in Spain

DRALEGA
Start date: October 26, 2023
Phase:
Study type: Observational

The 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.

NCT ID: NCT05873062 Completed - Clinical trials for Myoclonus Epilepsies, Progressive

Safety, Blood Levels and Effects of AUT00201 in Patients With MEAK

AUT022201
Start date: May 12, 2023
Phase: Phase 1
Study type: Interventional

A randomized, double-blind, placebo-controlled, crossover study to assess the safety, tolerability, and pharmacokinetics of single doses of AUT00201 at 100 mg or matching placebo in patients with myoclonus epilepsy and ataxia due to potassium channel mutation (MEAK).