Clinical trials: Epilepsy
Epilepsy
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.
- Trial name
- NCT05076838
- Testing
- Diazepam Nasal Spray [Valtoco]
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- Neurelis, Inc.
Epilepsy
Acute Recording of Stereotyped High-Frequency Oscillations
Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates >=1kHz and deliver…
- Trial name
- NCT05439655
- Testing
- Brain Interchange System
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Mayo Clinic
Epilepsy in Children
Getting SMART for Pediatric Epilepsy
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
- Trial name
- NCT05439876
- Testing
- Melatonin
- Where
- Taiwan
- Volunteers
- 147 people
- Sponsor
- National Taiwan University Hospital
Autism Spectrum Disorder, EEG With Periodic Abnormalities
Safety and Efficacy of tPBM for Epileptiform Activity in Autism
For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or…
- Conditions
- Autism Spectrum Disorder, EEG With Periodic Abnormalities, Epilepsy, Neurodevelopmental Disorders
- Trial name
- tPBM (NCT06352372)
- Testing
- noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Richard Frye
Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand [18F]MNI-792…
- Trial name
- NCT02497235
- Testing
- TAK-935, [18F]MNI-792 (tracer)
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Takeda
Epilepsy
TAK-935 Multiple Rising Dose Study in Healthy Participants
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple rising doses of TAK-935 in healthy participants.
- Trial name
- NCT02539134
- Testing
- TAK-935
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Takeda
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
15q Duplication Syndrome, CDKL5 Deficiency Disease
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.
- Trial name
- NCT03694275
- Testing
- Soticlestat
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Takeda
Epilepsy, Dravet Syndrome (DS)
A Study of Soticlestat in Adults and Children With Rare Epilepsies
The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day.
- Conditions
- Epilepsy, Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
- Trial name
- Endymion 1 (NCT03635073)
- Testing
- Soticlestat
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 156 people
- Sponsor
- Takeda
Dravet Syndrome (DS)
A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS.
- Trial name
- NCT04940624
- Testing
- Soticlestat
- Where
- 66 sites in United States, Australia and 16 more
- Volunteers
- 144 people
- Sponsor
- Takeda
Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS).
- Trial name
- NCT05163314
- Testing
- Soticlestat
- Where
- 116 sites in United States, Australia and 18 more
- Volunteers
- 352 people
- Sponsor
- Takeda
Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
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.
- Trial name
- NCT06422377
- Testing
- Soticlestat
- Where
- Denmark
- Volunteers
- 1 people
- Sponsor
- Takeda
Refractory Epilepsy
Optimal Stimulation Parameters to Disrupt Epileptiform Activity
Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective…
- Trial name
- NCT06141668
- Testing
- Neurostimulation
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massachusetts General Hospital
Primary Generalized Epilepsy
Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures
This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures.
- Trial name
- NCT03678753
- Testing
- Cenobamate
- Where
- 116 sites in United States, Australia and 10 more
- Volunteers
- 169 people
- Sponsor
- SK Life Science, Inc.
Transformed Migraine, Chronic Daily Headache
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
This study will compare a local anesthetic technique that has been used to treat subjects suffering from transformed migraines (chronic migraines) versus medical management with traditional antidepressant Amitriptyline / Elavil.
- Trial name
- NCT02090998
- Testing
- SPG Block with 5% Lidocaine gel, Amitriptyline
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Rutgers, The State University of New Jersey
Epilepsy; Seizure
Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy
This project studies how 2-deoxy-glucose (2DG) pills are absorbed and distributed in people with epilepsy. 2DG is similar to glucose, the main energy source for the brain, but it cannot be used as energy.
- Trial name
- NCT05605301
- Testing
- Oral 2-Deoxy-D-Glucose (2DG)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Virginia
Treatment Resistant Depression (TRD)
Maintenance TMS in Treatment Resistant Depression
Electroconvulsive therapy (ECT) is one of the most efficacious treatments available for treatment-resistant depression (TRD). Although a maintenance ECT protocol exists, multiple barriers limit its use for long-term use.
- Trial name
- NCT06682299
- Testing
- Transmagnetic Stimulation, Electroconvulsive Therapy
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Austin Messner
Epilepsy
Staccato Alprazolam and Photoparoxysmal Response
The purpose of this study is to determine whether people who usually have photosensitive epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato Alprazolam as compared to placebo.
- Trial name
- NCT02351115
- Testing
- B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 m, D= Inhaled Alprazolam 2 mg
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Nova Pneuma Inc.
Epilepsy
Add on Lacosamide Versus High Dose Monotherapy
This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.
- Trial name
- NCT01345058
- Testing
- lacosamide, levetiracetam
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Brigham and Women's Hospital
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