Clinical trials: Epileptic Encephalopathy
Prostate Cancer, Neuropathy
a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY
Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
- Conditions
- Prostate Cancer, Neuropathy, Epilepsy, Encephalopathy
- Trial name
- VENDY (NCT04290611)
- Testing
- Enzalutamide
- Where
- France
- Volunteers
- 500,000 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
CDKL5 Deficiency Disorder
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder
A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.
- Trial name
- Marigold (NCT03572933)
- Testing
- ganaxolone
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 101 people
- Sponsor
- Marinus Pharmaceuticals
SLC6A1 Neurodevelopmental Disorder (NDD), Developmental and Epileptic Encephalopathies (DEE)
SLC6A1-NDD Prospective Longitudinal Natural History Study
The overall objective of this prospective longitudinal natural history study is to collect clinical data to characterize and evaluate the natural course of SLC6A1-NDD and assess the feasibility of certain assessments for the…
- Trial name
- SPIRIT (NCT07531511)
- Where
- 3 sites in United States, France and 1 more
- Volunteers
- 60 people
- Sponsor
- UCB Biopharma SRL
SCN8A Developmental and Epileptic Encephalopathy Syndrome
Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEE
Extension study to evaluate how safe and tolerable the drug NBI-921352 is when used as adjunctive therapy in participants with SCN8A developmental and epileptic encephalopathy syndrome (SCN8A-DEE).
- Trial name
- NCT05226780
- Testing
- NBI-921352
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Neurocrine Biosciences
Epilepsy, Epileptic Encephalopathy
Tele-epic (Telemedicine for Epilepsy Care)
Epilepsy is a chronic condition that requires consistent follow-up aimed at seizure control, surveillance of comorbidities, monitoring of antiepileptic drugs (AED) levels and side effects.
- Conditions
- Epilepsy, Epileptic Encephalopathy, Refractory Epilepsy
- Trial name
- Tele-epic (NCT04496310)
- Testing
- Telemedicine
- Where
- 2 sites in Italy
- Volunteers
- 600 people
- Sponsor
- Azienda Usl di Bologna
SLC13A5 Citrate Transporter Disorder
Intrathecal Gene Therapy For SLC13A5 Citrate Transporter Disorder
Phase 1/2, open-label study to assess the efficacy and safety of a single lumbar intrathecal administration of TSHA-105 in individuals with SLC13A5 Citrate Transporter Disorder
- Trial name
- SLC13A5 (NCT07102524)
- Testing
- TSHA-105
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- TESS Research Foundation
Lennox-Gastaut Syndrome
Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
Lennox-Gastaut syndrome is a severe epileptic encephalopathy of childhood. In that syndrome, various type of seizure occur, mainly tonic seizures, atonic seizures and atypical absences. The tonic seizure occur mostly at night.
- Trial name
- NCT01370486
- Testing
- melatonin
- Where
- Switzerland
- Sponsor
- Institution de Lavigny
Seizure, Epileptic
Pathophysiology Based Therapy of Early Onset Epileptic Encephalopathies
Genetic 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.
- Trial name
- EE (NCT02968966)
- Testing
- Therapy regime
- Where
- Germany
- Sponsor
- University Hospital Tuebingen
Epileptic Encephalopathy, SCN2A Encephalopathy
A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety
A Multi-Center, Single-Arm Clinical Trial to Investigate the Efficacy and Safety of Elsunersen in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy
- Trial name
- NCT07019922
- Testing
- 1mg elsunersen, 0.5mg elsunersen
- Where
- 10 sites in United States, Brazil and 2 more
- Volunteers
- 40 people
- Sponsor
- Praxis Precision Medicines
STXBP1 Encephalopathy With Epilepsy
A Multicentric European Study to Promote Clinical Trial Readiness for STXBP1-related Disorders
STXBP1-related disorders (STXBP1-RD) are rare genetic neurodevelopmental disorders, caused by pathogenic variants in the gene STXBP1.
- Trial name
- ESCO (NCT06625112)
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- European STXBP1 Consortium
Developmental and Epileptic Encephalopathy, Epilepsy in Children
Developmental and Epileptic Encephalopathies Diagnosed Via Long-read Genome Sequencing
This study focuses on children with Developmental and Epileptic Encephalopathy (DEE), a severe form of epilepsy that often has a genetic origin.
- Trial name
- EEPILOG (NCT07396883)
- Testing
- Long-read Whole Genome Sequencing (lrWGS)
- Where
- 4 sites in France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Strasbourg, France
Focal Epilepsy, Intractable Epilepsy
Long-term Cardiac Monitoring in Epilepsy
The purpose of this research study to investigate, classify, and quantify chronic cardiac rhythm disorders in three groups of patients with epilepsy (intractable focal epilepsy, controlled focal epilepsy and symptomatic…
- Conditions
- Focal Epilepsy, Intractable Epilepsy, Epileptic Encephalopathy, Lennox Gastaut Syndrome
- Trial name
- LOOP (NCT03955432)
- Testing
- Reveal LINQ ICM System
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Northwell Health
Dravet Syndrome
A Double-blind Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen in Patients With Dravet Syndrome
The purpose of the study is to evaluate the efficacy, safety, and tolerability of zorevunersen in Patients with Dravet syndrome.
- Trial name
- NCT06872125
- Testing
- zorevunersen
- Where
- 61 sites in United States, China and 6 more
- Volunteers
- 170 people
- Sponsor
- Stoke Therapeutics, Inc
Genetic Disease, STXBP1 Encephalopathy With Epilepsy
STXBP1 and SYNGAP1 Related Disorders Natural History Study
The purpose of this study is to find out more about STXBP1 and SYNGAP1 related disorders. The information gathered by this study will be used to prepare for clinical treatment trials.
- Conditions
- Genetic Disease, STXBP1 Encephalopathy With Epilepsy, SYNGAP1-Related Intellectual Disability
- Trial name
- NCT06555965
- Testing
- Non-interventional study
- Where
- 5 sites in United States
- Volunteers
- 600 people
- Sponsor
- Children's Hospital of Philadelphia
Epilepsy, Dravet Syndrome
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
The 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.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Epilepsy, Epilepsy in Children
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).
- Conditions
- Epilepsy, Epilepsy in Children, Epilepsy; Seizure, Disease
- Trial name
- EPIK (NCT04639310)
- Testing
- XEN496
- Where
- 20 sites in United States, Australia and 3 more
- Volunteers
- 8 people
- Sponsor
- Xenon Pharmaceuticals Inc.
MEF2C, DEE
Genetic Developmental and Epileptic Encephalopathy Natural History Study for Clinical Trial Readiness
Phase 0 non-interventional longitudinal study of children and adults with Developmental and Epileptic Encephalopathy (DEE) due to a genetic cause. There are six arms of the study.
- Trial name
- NCT07413211
- Testing
- Observation
- Where
- United States
- Volunteers
- 22,068 people
- Sponsor
- Weill Medical College of Cornell University
Developmental and Epileptic Encephalopathy
A Clinical Trial of CAP-002 Gene Therapy in Pediatric Patients With Syntaxin-Binding Protein 1 (STXBP1) Encephalopathy
The goal of this clinical trial is to learn about the safety of CAP-002 gene therapy in children with Syntaxin-Binding Protein 1 (STXBP1) Encephalopathy.
- Trial name
- NCT06983158
- Testing
- gene therapy
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Capsida Biotherapeutics, Inc.
Epileptic Encephalopathy, Childhood-Onset
Memantine for Epileptic Encephalopathy
This study will evaluate the potential benefit of memantine hydrochloride as treatment for children with epileptic encephalopathy using a double-blind placebo-controlled cross-over design.
- Trial name
- NCT03779672
- Testing
- Memantine Hydrochloride 10 mg
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Kenneth Myers, MD
GNAO1, Dystonia
Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders
The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders.
- Conditions
- GNAO1, Dystonia, Epilepsy, Development Delay
- Trial name
- ZINCGNAO1 (NCT06412653)
- Testing
- Zinc Acetate Dihydrate
- Where
- Germany
- Volunteers
- 13 people
- Sponsor
- Children's University Hospital Cologne, Germany