Clinical trials: Status Epilepticus
Super-Refractory Status Epilepticus
An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus
This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these…
- Trial name
- NCT02433314
- Testing
- SAGE-547
- Sponsor
- Supernus Pharmaceuticals, Inc.
Epilepsy
A Survey of Midazolam in People With Status Epilepticus
This study is a survey in Japan of midazolam oromucosal solution used to treat people with status epilepticus. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the…
- Trial name
- NCT05313308
- Testing
- Midazolam
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Clinigen K.K.
Stereotypical Prolonged Seizures
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
- Trial name
- NCT05076617
- Testing
- Staccato alprazolam
- Where
- 136 sites in United States, Australia and 10 more
- Volunteers
- 300 people
- Sponsor
- UCB Biopharma SRL
Nonconvulsive Status Epilepticus, Seizures
Does Use of Rapid Response EEG Impact Clinical Decision Making
This study is designed as a prospective, non-randomized, observational, multicenter clinical trial. The primary aim of this study is to observe if the use of the rapid responds electroencephalography (EEG) system impacts…
- Trial name
- DECIDE (NCT03534258)
- Testing
- Ceribell Rapid Response EEG, Survey
- Where
- 5 sites in United States
- Volunteers
- 164 people
- Sponsor
- Ceribell Inc.
Status Epilepticus
LORA-PITA IV General Investigation
Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.
- Trial name
- NCT03905798
- Testing
- Lorazepam
- Where
- Japan
- Volunteers
- 206 people
- Sponsor
- Pfizer
Nervous System Diseases
Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan
The purpose of this study is to assess the efficacy, safety and pharmacokinetics of MHOS/SHP615 administered buccally in children with status epilepticus (convulsive) in a healthcare setting.
- Trial name
- NCT03336645
- Testing
- SHP615
- Where
- 23 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Shire
Status Epilepticus, Convulsive Status EPILEPTICUS
Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
This study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.
- Conditions
- Status Epilepticus, Convulsive Status EPILEPTICUS, Non Convulsive Status Epilepticus, Epilepsy
- Trial name
- NCT03350035
- Testing
- IV Ganaxolone active
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- Marinus Pharmaceuticals
Super-Refractory Status Epilepticus
A Study With SAGE-547 for Super-Refractory Status Epilepticus
This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).
- Trial name
- NCT02477618
- Testing
- SAGE-547
- Where
- 171 sites in United States, Austria and 14 more
- Volunteers
- 132 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Stereotypical Prolonged Seizures
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to…
- Trial name
- NCT05077904
- Testing
- Staccato alprazolam
- Where
- 183 sites in United States, Australia and 11 more
- Volunteers
- 350 people
- Sponsor
- UCB Biopharma SRL
Super-refractory Status Epilepticus
Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in participants in super-refractory status epilepticus (SRSE).
- Trial name
- SRSE (NCT02052739)
- Testing
- SAGE-547
- Where
- 17 sites in United States
- Volunteers
- 25 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Status Epilepticus
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
The purpose of this study is to determine the efficacy, safety and pharmacokinetics of Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.
- Trial name
- NCT02239380
- Testing
- Lorazepam
- Where
- 20 sites in Japan
- Volunteers
- 26 people
- Sponsor
- Pfizer
Status Epilepticus
Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE)
This study is designed to optimize the dosing regimen and evaluate the preliminary safety and efficacy of Intravenous (IV) ganaxolone as adjuvant therapy for participants with ESE receiving initial IV antiepileptic drug (AED)…
- Trial name
- NCT05757544
- Testing
- IV Ganaxolone
- Sponsor
- Marinus Pharmaceuticals
Altered Mental Status, Generalized Nonconvulsive Seizure Disorder
Putting Electroencephalography (EEG) in the Emergency Department
The aim of the proposed research is to compare the diagnostic accuracy of a portable wireless electroencephalography (EEG) device (Biosignal Micro-EEG) to standard EEG in identifying abnormal EEG patterns (mainly non-convulsive…
- Conditions
- Altered Mental Status, Generalized Nonconvulsive Seizure Disorder, Status-epilepticus
- Trial name
- NCT01355211
- Where
- United States
- Volunteers
- 261 people
- Sponsor
- Bio-Signal Group Corp.
Nervous System Diseases
Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting
The purpose of this study is to determine if the investigational treatment, MHOS/SHP615, is safe and effective in children with status epilepticus (SE) (convulsive) in the community setting.
- Trial name
- NCT03336450
- Testing
- SHP615, MHOS/SHP615
- Where
- 23 sites in Japan
- Volunteers
- 3 people
- Sponsor
- Shire
Mitochondrial Diseases, Drug Resistant Epilepsy
A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy
This is a parallel-arm, double-blind, placebo-controlled study with a screening phase that includes a 28-day run-in phase to establish baseline seizure frequency, followed by a 24-week, randomized, placebo-controlled phase.
- Conditions
- Mitochondrial Diseases, Drug Resistant Epilepsy, Leigh Disease, Leigh Syndrome
- Trial name
- MIT-E (NCT04378075)
- Testing
- Vatiquinone
- Where
- 27 sites in United States, Canada and 7 more
- Volunteers
- 68 people
- Sponsor
- PTC Therapeutics
Status Epilepticus
Study of Midazolam in Healthy Adults
This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared with seizalam in healthy…
- Trial name
- NCT04679623
- Testing
- Midazolam, Seizalam
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Rafa Laboratories
Refractory Status Epilepticus
To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)
This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED)…
- Trial name
- NCT05814523
- Testing
- Ganaxolone, Standard of care
- Where
- 52 sites in Austria, Belgium and 14 more
- Sponsor
- Marinus Pharmaceuticals
Status Epilepticus
Randomized Therapy In Status Epilepticus
This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).
- Trial name
- RAISE (NCT04391569)
- Testing
- Ganaxolone
- Where
- 74 sites in United States, Australia and 1 more
- Volunteers
- 100 people
- Sponsor
- Marinus Pharmaceuticals