Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasms

Diseases and Abnormalities at or Before Birth

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Rare Diseases

Sclerosis

Seizures

Tuberous Sclerosis

Focal Cortical Dysplasia

Behavioral Symptoms

Congenital Abnormalities

Malformations of Cortical Development

Neurologic Manifestations

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

Liquid suspension of radiprodil, at concentrations 0.25 mg/mL or 2.50 mg/mL for 1% and 10% formulation respectively. It will be administered twice a day (bid) either orally or via gastric or nasogastric tube.

Radiprodil is an orally active, negative allosteric modulator of the NR2B subunit of the NMDA receptor.

Radiprodil

Clinical Operations

Catherine Riney

Study RAD-GRIN-201 is a phase 1B/2A trial to assess safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in participants with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A and one year in Part B/long-term treatment period. The treatment period in Part B may be extended based on a favorable benefit/risk profile.

Approximately 20 participants with TSC and 10 participants with FCD type II will be enrolled.

The effects of radiprodil are assessed in participants with treatment-resistant seizures (with or without behavioral symptoms). The daily doses of radiprodil will be individually titrated for every participant and all the participants will receive study drug.

This study is divided into the following periods:

PART A:

* Screening/Observation Period (up to six(6) weeks): Investigators assess eligibility followed by an Observation Period (at least four(4) weeks) to evaluate seizure frequency.
* Titration Period (approx. four(4) weeks): Radiprodil twice daily will be administered in escalating doses and plasma concentrations, safety, and tolerability assessed. Once a safe and potentially effective dose has been established, the participant will immediately enter the Maintenance Period.
* Maintenance Period (approx. twelve(12) weeks): The participant will continue to take the safe and potentially effective dose identified during the Titration Period. At the end of the Maintenance Period the participant will either be invited to enter Part B or the Tapering and Safety Follow-up Period.
* Tapering (15 days) and Safety Follow-up Period (14 days): a participant who doesn't take part in the long-term treatment period (Part B) will taper (ie gradually decrease) the study medicine for 15 days and enter a safety Follow-up Period (14 days). In this case, the participant will have one (1) last visit at the end of the safety Follow-up Period.

PART B:

* Long-Term Treatment Period (one(1) year): During the Long-Term Treatment Period (Part B), participants will continue taking radiprodil at the usual dose level and making regular visits to the study site.
* Tapering (15 days) and Safety Follow-up Period (14 days): at the end of the long-term treatment period (Part B), the participant will taper (ie gradually decrease) the study medicine for 15 days and enter a safety Follow-up Period (14 days) after his/her last dose of radiprodil. The participant will have one (1) last visit at the end of the safety Follow-up Period.

A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II

A Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Radiprodil in Patients With Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II

Frequency, type, severity and duration of adverse events, serious adverse events and adverse drug reactions.

The clinical laboratory tests include Hematology, Serum Chemistry and Coagulation

A complete physical and neurological examination according to standard of care excluding the genitourinary examination will be performed

changes from Baseline to End of study for systolic blood pressure

changes from Baseline to End of study for diastolic blood pressure

changes from Baseline to End of Treatment for pulse rate

Assessed by 8- to 24- hour video electroencephalogram

The ABC-2C is a standardized 58-item caregiver-reported problem-behavior rating scale, originally designed to assess treatment effects in people with intellectual disabilities. Each item is scored from 0 (never a problem) to 3 (severe problem). Items load onto one of five empirically derived subscales: Irritability, Agitation, \& Crying (15 items); Lethargy/Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity/Noncompliance (16 items); and Inappropriate Speech (4 items). A total score would range from 0 to 174.

The CaGI-C is a 7-point caregiver-rated scale ranging from 1 (very much improved) to 7 (very much worse).

The CGI scale is a clinician-rated measures of change of a symptom or condition, using a single item, 6- or 7-point scale. The CGI-C scale ranges from 1 ("Very much worse") to 7 ("Very much improved").

The PedsQL is a 23-item generic health status instrument assessing 5 domains of health in children. It's a 0-100 scale, and higher scores are indicative of better health-related quality of life.

The CBI is a validated scale providing information regarding the impact of caregiving on the lives of caregivers. It comprises 24 closed questions divided into 5 dimensions. Each dimension includes 4 or 5 items. Each item is given a score between 0 and 4, where higher scores indicate greater caregiver burden.

The C-SSRS is a validated tool designed to systematically evaluate the severity and intensity of suicidal ideation and behavior. The scoring system ranges from 0 to 5 for suicidal ideation and from 0 to 25 for suicidal behavior, with higher scores indicating greater severity or greater frequency of suicidal thoughts or actions.

GRIN Therapeutics, Inc.

Heart and Blood Diseases

Musculoskeletal Diseases

Brain Neoplasms

Stroke

Epilepsy

Encephalitis

Gliosis

Polymicrogyria

Klippel-Trenaunay-Weber Syndrome

Sturge-Weber Syndrome

Hemimegalencephaly

Infarction

Brain Stem Infarctions

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Neuroinflammatory Diseases

Brain Infarction

Ischemia

Brain Ischemia

Necrosis

Angiomatosis

Hemangioma

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Central Nervous System Neoplasms

Nervous System Neoplasms

Megalencephaly

Craniofacial Abnormalities

Musculoskeletal Abnormalities

Klippel-Trenaunay Syndrome

Parkes Weber Syndrome

Weber Syndrome

Rasmussen Encephalitis

Participants undergoing intra-operative brain tissue stiffness measurements using a digital tonometer. Evaluated brain tissue is both presumed normal and abnormal based on results of pre-operative evaluations.

Once the brain is exposed during surgery, a sterilized digital tonometer will be used to obtain brain tissue stiffness measurements at various locations of the cortex established based on results of pre-operative work-up. Precise stereotactic coordinates for each measurement will be recorded in a neuronavigation software to facilitate comparisons with results of other tests.

Intra-operative brain tonometry

Aria Fallah, MD

Refractory epilepsy, meaning epilepsy that no longer responds to medication, is a common neurosurgical indication in children. In such cases, surgery is the treatment of choice. Complete resection of affected brain tissue is associated with highest probability of seizure freedom. However, epileptogenic brain tissue is visually identical to normal brain tissue, complicating complete resection. Modern investigative methods are of limited use.

An important subjective assessment during surgery is that affected brain tissue feels stiffer, however there is presently no way to determine this without committing to resecting the affected area. It is hypothesized that intra-operative use of a tonometer (Diaton) will identify abnormal brain tissue stiffness in affected brain relative to normal brain. This will help identify stiffer brain regions without having to resect them.

The objective is to determine if intra-operative use of a tonometer to measure brain tissue stiffness will offer additional precision in identifying epileptogenic lesions.

In participants with refractory epilepsy, various locations on the cerebral cortex will be identified using standard pre-operative investigations like magnetic resonance imagin (MRI) and positron emission tomography (PET). These are areas of presumed normal and abnormal brain where the tonometer will be used during surgery to measure brain tissue stiffness. Brain tissue stiffness measurements will then be compared with results of routine pre-operative and intra-operative tests. Such comparisons will help determine if and to what extent intra-operative brain tissue stiffness measurements correlate with other tests and help identify epileptogenic brain tissue.

24 participants have already undergone intra-operative brain tonometry. Results in these participants are encouraging: abnormally high brain tissue stiffness measurements have consistently been identified and significantly associated with abnormal brain tissue.

If the tonometer adequately identifies epileptogenic brain tissue through brain tissue stiffness measurements, it is possible that resection of identified tissue could lead to better post-operative outcomes, lowering seizure recurrences and neurological deficits.

Rationale: Refractory epilepsy, meaning epilepsy that no longer responds to medication, is a common neurosurgical indication in children. Focal cortical dysplasia (FCD) is the most common cause. Tuberous sclerosis complex (TSC) is a rare genetic disease causing epilepsy in over 90% of affected patients. This epilepsy can also become refractory to medication. In such cases of FCD or TSC, surgery is the treatment of choice. Complete resection of brain tissue affected by FCD or TSC is associated with highest probability of seizure freedom. However, epileptogenic brain tissue is visually identical to normal brain tissue, complicating complete resection. Modern investigative methods such as magnetic resonance imaging (MRI), electro-encephalography (EEG) and positron emission tomography (PET), are of limited use. Failure to achieve complete resection may lead to seizure recurrence, which is costly and requires additional surgeries, increasing risks of morbidity and mortality compared to achieving remission.

Changes in tissue stiffness due to an underlying pathology are common in medicine, especially in neurological disorders. An important subjective assessment during epilepsy surgery, particularly in FCD cases, is that affected brain tissue feels stiffer. However, there is currently no way to determine stiffness without committing to resecting the affected area.

Hypothesis: Epileptogenic brain tissue stiffness, as measured intra-operatively using a digital tonometer (Diaton), will likely be increased relative to normal brain tissue. This could allow identification of regions of higher stiffness without having to commit to resection.

The tonometer is a widely-used and FDA-approved tool to measure intraocular pressure. It is a simple and reliable tool to measure brain tissue stiffness without obstructing the operative field. It requires only minimal contact in brain tissue.

This study is multicentric and includes University of California, Los Angeles (UCLA) Mattel Children's Hospital in Los Angeles and Sainte-Justine University Hospital in Montreal. Results from 24 participants in a preliminary study from UCLA Mattel Children's Hospital were encouraging, prompting expansion of the study to include both sites.

Objectives:

Primary objective: To determine if intra-operative use of a tonometer to measure brain tissue stiffness will offer additional precision in identifying affected epileptogenic brain tissue, notably in FCD. This could also allow identification of resection margins.

Secondary objective: Eventually, to investigate is epilepsy surgery guided by brain tissue stiffness measurements can lead to better post-operative outcomes, especially regarding seizure recurrences and neurological deficits.

Methods: Participants with refractory epilepsy and considered candidates for surgery following a multidisciplinary meeting and consultation with a neurosurgeon, will undergo standard pre-operative investigations such as MRI, EEG and PET, to identify regions of presumed normal and abnormal brain. Precise locations in both presumed normal and abnormal brain will be identified for intra-operative brain stiffness measurements using the tonometer. Measurements will be taken on all lobes exposed during surgery.

During surgery, a craniotomy will be performed and the dura mater will be folded to maximize brain exposition. Once the brain is exposed, a sterilized tonometer will be used to obtain brain tissue stiffness measurements at all predetermined locations of the cortex. Precise stereotactic coordinates for each measurement will be recorded in a neuronavigation software to facilitate comparisons with results of other tests. Brain tissue stiffness measurements will then be compared to results of aforementioned pre-operative tests, as well as results of routine intra-operative tests, namely electro-corticography (ECoG) and histopathological analysis of resected brain tissue (if brain tissue is ultimately resected).

With this method, it will be possible to determine if and to what extent intra-operative use of the tonometer can identify epileptogenic brain tissue.

There are no known risks to the patient associated with intra-operative use of the tonometer. Data collection adds approximately 10 minutes to surgery, which typically lasts around 7 hours (420 minutes). Therefore, time in surgery and general anesthesia is only lengthened by 2%.

Importantly, no surgical decision concerning resection of brain tissue is currently based on brain tissue stiffness measurements obtained with the tonometer.

Recruiting: Participants suffering from refractory epilepsy and deemed candidates for surgical treatment during a multidisciplinary meeting will consult with a neurosurgeon. During this consultation, if surgery is adequate and participant is eligible, the present study will be explained and discussed with the participant and his/her parent(s) or legal tutor(s). They will receive the informed consent form. Their questions will be answered. Time will be given to think about their participation to this study. If they consent, consent will be obtained through signing the informed consent form. If they refuse to participate, medical and surgical treatment will resume as planned.

File review: Medical files of patients prospectively recruited will be reviewed with the participant's consent. Data relevant to the study includes: sex, ethnicity, age at onset of epilepsy, age at surgery, number of antiepileptic medications, etiology, video-EEG results, MRI results, PET results, digital pictures of the brain during surgery, individual brain stiffness measurements taken with the tonometer along with co-recorded neuronavigation images and coordinates.

Tests: Before surgery, each participant will undergo routine pre-operative work-up including video-EEG, MRI and PET. During surgery, ECoG will be performed. If brain tissue is resected, in will be analyzed by pathologist to establish a histopathological diagnosis. These are routine investigations in epilepsy surgery. They are not modified by the results of tonometry. The only additional test is intra-operative brain tissue stiffness measurements using the tonometer. As discussed previously, this is not associated with any risks to the participant.

It is predicted that 150 participants will be enrolled across both sites for this study. Anonymized data for each patient will be shared between both sites.

Importantly, there are no possible controls for such a study. Post-mortem brain tissue undergoes irreversible biomechanical changes and no healthy patient undergoes comparable neurosurgical procedures. To overcome this issue, an experimental model involving intra- and inter-participant comparisons is used.

Data analysis: Once data will be collected, statistical analysis will be performed. Continuous data will be reported using means and standard-deviations. Dichotomic data will be reported using frequencies and percentages. Mean and standard-deviations of brain tissue stiffness measurements will be compared for each covariable category using a t-test or ANOVA. Findings will be reported with a beta coefficient, 95 percent confidence intervals and p-values. P-values under 0.05 will be considered statistically significant. Further statistical analyses will be determined during the study.

Timeframe: This study is predicted to last 36 months. Recruiting and treatment of participants, along with data collection will be performed initially. Following this, data will be analyzed and results discussed. Article(s) related to this study will be written afterwards.

There are no possible controls for such a study. Post-mortem brain tissue undergoes irreversible biomechanical changes and no healthy patient undergoes comparable neurosurgical procedures. To overcome this issue, an experimental model involving intra- and inter-participant comparisons is used. A single group of participants will undergo brain tonometry and resulting brain tissue stiffness measurements will be compared in predicted normal and abnormal brain tissue (as identified by pre-operative work-up) in each participant and between participants.

No masking. Participants as well as caregivers and investigators will all be aware that patients are undergoing intra-operative brain tonometry (single arm study).

Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery

Use of a Tonometer to Identify Focal Cortical Dysplasia and Tuberous Sclerosis Complex During Pediatric Epilepsy Surgery

Relevant data will be shared through publications and presentations. These include brain tissue stiffness measurements in normal and abnormal brain, as well as how they correlate to results of other, standard pre- and intra-operative evaluations.

Brain tonometry is a novel diagnostic approach, therefore normal and abnormal brain tissue stiffness values are not known. Measurements will be taken on presumed normal cerebral cortex, based on results of preoperative evaluations (magnetic resonance imaging, electro-encephalography, positron emission tomography), to establish potential normal brain tissue stiffness values.

Brain tonometry is a novel diagnostic approach, therefore normal and abnormal brain tissue stiffness values are not known. Measurements will be taken on presumed pathological (ex.: focal cortical dysplasia, tuberous sclerosis complex) cerebral cortex, based on results of preoperative evaluations (magnetic resonance imaging, electro-encephalography, positron emission tomography), to establish potential pathological brain tissue stiffness values.

Precise stereotactic coordinates for each brain tissue stiffness measurement will be recorded in a neuronavigation software. This will allow aggregation of brain tissue stiffness measurements and results of routine preoperative (MRI, EEG, PET), as well as intra-operative tests (ECoG, histopathological analysis of resected brain tissue) on a 3D model of each patient's brain.

With this method, each brain tissue stiffness measurement can be compared to presence or absence of an underlying lesion on MRI; to presence or absence of epileptogenic foci on EEG; to presence of iso- or hypometabolism on PET; to presence or absence of epileptogenic foci on ECoG; to pathological diagnosis and severity of cortical disorganization on histopathological analysis.

This will give insight into how well brain tissue stiffness measurements correlate with, and potentially identify, structural and functional epileptic brain anomalies.

The intraoperative use of the tonometer should not affect patient outcome. To support this, surgical complications, as they relate to the participants of this study, will be recorded on clinical follow-up, to be compared with the available literature. Number of patients with surgical complications, as well as the nature of the complications will be recorded. Of note, there are no additional visits required for this study after participation in the operating room. Follow-up remains as planned according the the nature of the patient's condition and surgery.

The intraoperative use of the tonometer should not affect patient outcome. To support this, seizure freedom, as it relates to the participants of this study, will be recorded on clinical follow-up, to be compared with the available literature. Number of patients achieving seizure freedom, as well as number of patients not achieving seizure freedom will be recorded. Time to seizure recurrence will also be recorded. Of note, there are no additional visits required for this study after participation in the operating room. Follow-up remains as planned according the the nature of the patient's condition and surgery.

Université de Montréal

University of California, Los Angeles

Aria Fallah, MD, MSc, FRCSC, FAANS, FAAP; Neurosurgery

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

This group will be treated with everolimus 7-28 days prior to surgery

This group will be enrolled as reference subjects, and will be undergoing routine surgery as part of standard of care treatment. No intervention will be provided to these subjects as part of the study.

This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not

Orrin Devinsky, MD

The purpose of this study is to measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, and another will not. Researchers will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not. Previous studies have suggested that Everolimus may reduce seizure activity in TSC patients by decreasing mTOR signaling. Since patients with FCD may also have excess mTOR signaling brain activity, Everolimus may also reduce seizure activity in these patients.

The drug Everolimus is approved by the Food and Drug Administration to treat specific types of breast, pancreatic, and kidney cancer, a kidney tumor called an angiomyolipoma (common in patients with TSC), and TSC patients who have a brain tumor called a subependymal giant cell astrocytoma (SEGA). However, in this research it is considered to be an investigational since it is not approved for reduction in mTOR signaling and a decrease in seizure frequency. Researchers believe that Everolimus may be useful in reducing something called cortical hyperexcitability, which is the excess brain activity that can contribute to seizures.

This is a single center open-label pilot clinical trial of patients with TRE, ages 1 to 40 years old, with TSC or FCD who are scheduled for epilepsy surgery. Patients will be treated with everolimus for 7 to 28 days prior to epilepsy surgery with extension of time from 7 to 28 days in successive cohorts of patients. The initial cohort of at least three patients will be treated for 7 days and after the safety of therapy is assured for this group, there will be an extension of the treatment to 14 days for at least three patients. This will be extended at one week intervals/three patient groups to a maximum treatment duration of 28 days. Resected brain tissue will be analyzed for activation of mTORC1 and mTORC2 signaling pathways, glutamatergic and GABA-ergic neurotransmission using histochemistry, genetic analysis, as well as extracellular field recordings in acute ex-vivo brain slices from surgery. A blood sample, collected at the time of surgery, will be analyzed for everolimus levels and VEGF-D. All patients will undergo standardized intra-operative ECoG recordings over the primary epileptogenic region and reviewed blindly.

Subjects will be in the study for 7-28 days. The investigators will study variables listed in specific aims 1 and 2 in TSC and FCD patients treated with 7 to 28 days of everolimus and compare these to untreated control patients with TRE and TSC or FCD. A concurrent comparison group of 12 subjects will also be enrolled. They will all be undergoing routine surgery for the diagnosis of TRE with TSC or FCD.

All study procedures will be performed at the Comprehensive Epilepsy Center (CEC) with the exception of the surgery, which will be performed at Tisch Hospital.

A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD

.Adverse event monitoring should be continued for at least 30 days (or 5 half-lives, whichever is longer) following the last dose of study treatment

HMGB1 expression is measured through label-free quantification (LFQ). LFQ is a method in mass spectroscopy that determines the relative amount of proteins in biological samples. The unit of measure is LFQ intensity; a higher LFQ intensity indicates greater HMGB1 expression.

NYU Langone Health

This group will be treated with everolimus 7-28 days prior to surgery

Everolimus: This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not

Treated Subject

Reference Subject

Treated Subjects

Reference Subjects

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Orrin Devinsky

Number of Patients With Adverse Events

Blood Everolimus Levels

This group will be treated with everolimus 7-28 days prior to surgery Everolimus: This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not

This group will be enrolled as reference subjects, and will be undergoing routine surgery as part of standard of care treatment. No intervention will be provided to these subjects as part of the study

Blood Total VEGF Levels (Not Only VEGF-D)

mTOR Brain Tissue-S6 Phosphate by Western Blot

HMGB1 Expression in Brain Tissue

Overall Study

Drug Resistant Epilepsy

Hyperplasia

Epilepsies, Partial

Sequencing of paired blood-brain DNA samples

Sampling of blood, frozen resected tissues, and cerebrospinal fluid (CSF)

Amelie YAVCHITZ, MD

Mathilde Chipaux, MD

Amélie Yavchitz, MD

Georg Dorfmüller, MD

Stéphanie Baulac, PhD

Mathilde CHIPAUX, MD

Stephanie Boulac, PhD

Brain somatic mutations in genes belonging to the mTOR signaling pathway are a frequent cause of cortical malformations, including focal cortical dysplasia or hemimegalencephaly.

The present study aims to search for brain somatic mutations in paired blood-brain samples and perform functional validation in children with drug-resistant focal epilepsy

cortical tissu removed from neurosurgical intervention of epilespy

Genetic and Electrophysiologic Study in Focal Drug-resistant Epilepsies

Detection of brain somatic mutations and functional studies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II	NCT06392009	Tuberous Sclero... Focal Cortical ...	Radiprodil	6 Months - 18 Years	GRIN Therapeutics, Inc.
Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery	NCT04344626	Epilepsy Focal Cortical ... Tuberous Sclero... Hemimegalenceph... Polymicrogyria Rasmussen Encep... Sturge-Weber Sy... Gliosis Stroke Tumor, Brain	Intra-operative...	-	University of California, Los Angeles
A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD	NCT02451696	Epilepsy Tuberous Sclero... Focal Cortical ...	Everolimus	2 Years - 40 Years	NYU Langone Health
A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD	NCT02451696	Epilepsy Tuberous Sclero... Focal Cortical ...	Everolimus	2 Years - 40 Years	NYU Langone Health
Genetic and Electrophysiologic Study in Focal Drug-resistant Epilepsies	NCT02890641	Refractory Foca... Focal Cortical ... Hemimegalenceph... Tuberous Sclero... Mild Malformati...	Sampling of blo...	3 Months - 25 Years	Fondation Ophtalmologique Adolphe de Rothschild
Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery	NCT04344626	Epilepsy Focal Cortical ... Tuberous Sclero... Hemimegalenceph... Polymicrogyria Rasmussen Encep... Sturge-Weber Sy... Gliosis Stroke Tumor, Brain	Intra-operative...	-	University of California, Los Angeles

Spots Global Cancer Trial Database for focal cortical dysplasia