Clinical trials: Encephalopathy
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
Hepatic Encephalopathy, Urea Cycle Disorders
A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
The purpose of this study is to determine the safety and tolerability of GT4P administered orally as a single dose, and twice daily for 7 consecutive days, to subjects with hepatic impairment with cirrhosis (Child-Pugh scores of…
- Trial name
- NCT00986895
- Testing
- HPN-100
- Where
- 2 sites in Ukraine
- Volunteers
- 32 people
- Sponsor
- Amgen
Mild Hepatic Encephalopathy
AST-120 Used to Treat Mild Hepatic Encephalopathy
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
- Trial name
- ASTUTE (NCT00867698)
- Testing
- AST-120
- Where
- 38 sites in United States
- Volunteers
- 148 people
- Sponsor
- Ocera Therapeutics
Epilepsy, Epilepsy in Children
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
To assess the long-term safety and tolerability of XEN496 in pediatric subjects with KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE) who had participated in the primary study (XPF-009-301).
- Conditions
- Epilepsy, Epilepsy in Children, Epilepsy; Seizure, Disease
- Trial name
- EPIK-OLE (NCT04912856)
- Testing
- XEN496
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 8 people
- Sponsor
- Xenon Pharmaceuticals Inc.
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
Dravet Syndrome, Seizure Disorder
A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind, placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive…
- Trial name
- NCT02682927
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 55 sites in United States, Australia and 9 more
- Volunteers
- 262 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Dravet Syndrome
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet…
- Trial name
- NCT02926898
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 87 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Developmental and Epileptic Encephalopathy 1
A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Relutrigine in Participants with Developmental and Epileptic…
- Trial name
- EMERALD (NCT07010471)
- Testing
- 1.0mg/kg/day PRAX-562, 1.5mg/kg/day PRAX-562
- Where
- 11 sites in United States, Australia and 1 more
- Volunteers
- 160 people
- Sponsor
- Praxis Precision Medicines
SCN2A Encephalopathy, SCN8A Encephalopathy
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
- Trial name
- EMBOLD (NCT05818553)
- Testing
- PRAX-562
- Where
- 8 sites in United States, Israel and 2 more
- Volunteers
- 77 people
- Sponsor
- Praxis Precision Medicines
Neurologic Disorders, Nervous System Diseases
Neurologic Stem Cell Treatment Study
This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will…
- Conditions
- Neurologic Disorders, Nervous System Diseases, Neurodegenerative Diseases, Neurological Disorders
- Trial name
- NEST (NCT02795052)
- Testing
- Intravenous and Intranasal BMSC
- Where
- 3 sites in United States, United Arab Emirates
- Volunteers
- 500 people
- Sponsor
- MD Stem Cells
Hepatic Encephalopathy
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function.
- Trial name
- NCT04128462
- Testing
- MNK-6105, Standard of Care
- Sponsor
- Mallinckrodt
KCNT1-Related Epilepsy
A Natural History Study of Participants With Potassium Sodium-Activated Channel Subfamily T Member 1 (KCNT1)-Related Epilepsy
The primary objective of the study is to characterize seizures in participants with KCNT1-related epilepsy. The secondary objectives are to characterize head growth, symptom severity, neurocognitive and social functions, adaptive…
- Trial name
- K1Te (NCT04924153)
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Biogen
Alzheimer Disease, Chronic Traumatic Encephalopathy
Visualizing Brain Proteinopathies Using [F-18]Flornaptitril-PET in the Prediction of Clinical Progression of Mild Cognitive Impairment With Either Suspected Chronic Traumatic Encephalopathy or Alzheimer's Disease
CMK-0301 is a multi-site, randomized clinical trial to evaluate the safety and efficacy of [F-18]Flornaptitril-PET (F-18 FNT-PET) for the prediction of clinical progression of Mild Cognitive Impairment (MCI) with either Suspected…
- Trial name
- NCT06254469
- Testing
- [F-18]Flornaptitril
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- CereMark Pharma, LLC
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.
Developmental and Epileptic Encephalopathy
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed…
- Trial name
- NCT06908226
- Testing
- LP352
- Where
- 88 sites in United States, Australia and 15 more
- Volunteers
- 324 people
- Sponsor
- Longboard Pharmaceuticals
Dravet Syndrome, Lennox Gastaut Syndrome
Intermediate-Size Expanded Access Protocol (EAP) for LP352
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 participants with DEEs.
- Conditions
- Dravet Syndrome, Lennox Gastaut Syndrome, Developmental and Epileptic Encephalopathies
- Trial name
- NCT06149663
- Testing
- LP352
- Where
- 22 sites in United States, Australia
- Sponsor
- Longboard Pharmaceuticals
Cirrhosis, Hepatic Encephalopathy
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).
- Trial name
- HALT-HE (NCT00999167)
- Testing
- HPN-100
- Where
- 28 sites in United States
- Volunteers
- 189 people
- Sponsor
- Amgen
Acute Episode of Overt Hepatic Encephalopathy, Hepatic Encephalopathy
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
- Trial name
- STOP-HE (NCT01966419)
- Testing
- ornithine phenylacetate
- Where
- 131 sites in United States, Australia and 15 more
- Volunteers
- 231 people
- Sponsor
- Ocera Therapeutics, Inc.
Overt Hepatic Encephalopathy
Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).
- Trial name
- OHE (NCT03515044)
- Testing
- 40 mg Rifaximin SSD once daily, 40 mg Rifaximin SSD twice daily, 80 mg Rifaximin SSD once daily
- Where
- 34 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.