Clinical trials: Focal Cortical Dysplasia
Epilepsy, Tuberous Sclerosis Complex
A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD
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…
- Conditions
- Epilepsy, Tuberous Sclerosis Complex, Focal Cortical Dysplasia
- Trial name
- NCT02451696
- Testing
- Everolimus
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- NYU Langone Health
Pulmonary Embolism, Venous Thrombosis
XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis
The trial is an open-label, randomized, trial examining novel biomarkers of thrombosis in patients managed with rivaroxaban vs. standard care following treatment of pulmonary embolism (PE) with catheter-guided alteplase.
- Trial name
- XENITH (NCT02506985)
- Testing
- rivaroxaban, warfarin
- Volunteers
- 10 people
- Sponsor
- Susan Smyth
Cortical Dysplasia
Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy
The investigators are undertaking the first European Randomised Controlled Trial (RCT) for epilepsy surgery in children with FCD type II, to prospectively evaluate the role of the KD prior to surgery in improving seizure outcome.
- Trial name
- EDIBLE (NCT02261753)
- Testing
- Classical ketogenic diet
- Where
- 15 sites in United States, Austria and 6 more
- Volunteers
- 3 people
- Sponsor
- University College, London
Epilepsy and Focal Cortical Dysplasia II
A Study Investigating the Anti-epileptic Efficacy of Afinitor (Everolimus) in Patients With Refractory Seizures Who Have Focal Cortical Dysplasia Type II (FCD II)
This is a prospective, randomized, double-blind, placebo-controlled cross over study designed to evaluate the efficacy and safety of everolimus (trough 5-15 ng/mL) given as adjunctive therapy in patients with focal cortical…
- Trial name
- NCT03198949
- Testing
- Afinitor (everolimus)
- Where
- South Korea
- Volunteers
- 23 people
- Sponsor
- Yonsei University
Epilepsy, Focal Cortical Dysplasia
Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery
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.
- Conditions
- Epilepsy, Focal Cortical Dysplasia, Tuberous Sclerosis, Hemimegalencephaly
- Trial name
- NCT04344626
- Testing
- Intra-operative brain tonometry
- Where
- 2 sites in United States, Canada
- Sponsor
- University of California, Los Angeles
Focal Cortical Dysplasia, Tuberous Sclerosis Complex (TSC)
Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)
This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.
- Conditions
- Focal Cortical Dysplasia, Tuberous Sclerosis Complex (TSC), Hemimegalencephaly
- Trial name
- NCT07287202
- Testing
- SVG103
- Where
- 2 sites in Australia
- Volunteers
- 12 people
- Sponsor
- Sovargen
Refractory Epilepsy, Focal Epilepsy
Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and…
- Conditions
- Refractory Epilepsy, Focal Epilepsy, Focal Cortical Dysplasia
- Trial name
- SPREAD (NCT03321240)
- Testing
- visual and quantitative SEEG signal analysis, Resective epilepsy surgery procedure
- Where
- 11 sites in France
- Volunteers
- 240 people
- Sponsor
- University Hospital, Strasbourg, France
Tuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia
Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults
This is a Phase 1, open-label, 2-part study to evaluate the effect of multiple doses of oral carbamazepine or oral itraconazole on the plasma pharmacokinetic profile of radiprodil in healthy adult participants.
- Conditions
- Tuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia, Other Neurological Disorders
- Trial name
- NCT06965881
- Testing
- Radiprodil with Carbamazepine, Radiprodil with Itraconazole
- Where
- 2 sites in Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GRIN Therapeutics, Inc.
Tuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia
Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs.
This is a Phase 1, open-label, 3-period study to determine radiprodil's potential to act as a perpetrator of cytochrome P-450 (CYP) metabolic pathways and transporter pathways.
- Conditions
- Tuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia, Other Neurological Disorders
- Trial name
- NCT06975605
- Testing
- Radiprodil + co-administered drugs
- Where
- Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GRIN Therapeutics, Inc.
Epilepsy, Focal Cortical Dysplasia
First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study
The goal of this first-in-human study is to evaluate a novel ultraflexible microelectrode in children undergoing neurosurgery to remove tissue that causes epilepsy (seizures) in focal cortical dysplasia (FCD) or long-term…
- Trial name
- NCT06116279
- Testing
- Insertion of electrode during planned neurosurgery for epilepsy
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Drug-resistant Focal Epilepsies in Pediatric Population
Genetic and Electrophysiologic Study in Focal Drug-resistant Epilepsies
Brain somatic mutations are increasingly recognized as a major cause of focal epilepsies. These include mTOR pathway mutations underlying cortical malformations such as focal cortical dysplasia and hemimegalencephaly, and SLC35A2…
- Trial name
- GENEPHY (NCT02890641)
- Testing
- Sampling of blood, frozen resected tissues, and cerebrospinal fluid (CSF)
- Where
- France
- Volunteers
- 450 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
Drug Resistant Epilepsy
Fluorescence Guided Focal Cortical Dysplasia Surgery
Epilepsy is one of the most common neurological disorders, with one of the highest morbidity rates of all diseases. Despite the development of new anticonvulsant drugs, around a third of patients suffer from drug-resistant…
- Trial name
- FLUOFOCODYS (NCT07657975)
- Testing
- 5-ALA (Gliolan)
- Where
- 2 sites in France
- Volunteers
- 5 people
- Sponsor
- Hospices Civils de Lyon
Focal Cortical Dysplasia, Epilepsy
Mos-FED (Mosaicism in Focal Epilepsy Cortical Dysplasia Tissue)
Focal cortical dysplasia (FCD) is a malformation of brain development, the most common cause of drug-resistant epilepsy and often caused by mutations in mammalian target of rapamycin (mTOR) pathway genes.
- Trial name
- MosFED (NCT06053671)
- Testing
- Blood and nasal swab sampling
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- King's College Hospital NHS Trust
Pulmonary Embolism Acute, Pulmonary Embolism Acute Massive
Cohort Study on Treatment Comes of Catheter-based Therapy in Patients With Acute Pulmonary Embolism in Hong Kong
This retrospective cohort study (Hong Kong PECT Registry) compares treatment outcomes between different percutaneous catheter-based therapies in patients with acute pulmonary embolism (PE).
- Conditions
- Pulmonary Embolism Acute, Pulmonary Embolism Acute Massive, Pulmonary Embolism Subacute Massive
- Trial name
- HK-PECT (NCT07029841)
- Testing
- catheter-based therapy
- Where
- Hong Kong
- Volunteers
- 1,000 people
- Sponsor
- Chinese University of Hong Kong
Tuberous Sclerosis Complex, Focal Cortical Dysplasia
Astroscape: A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II
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…
- Trial name
- NCT06392009
- Testing
- Radiprodil
- Where
- 18 sites in Australia, Belgium and 6 more
- Volunteers
- 30 people
- Sponsor
- GRIN Therapeutics, Inc.
CASPR2-Antibody, Encephalitis Autoimmune
CASPR2 Encephalitis Initial Symptoms
Auto-immune encephalitides involve auto-antibodies targeting the central nervous system, and particularly the synapse and its structure, such as protein CASPR2.
- Conditions
- CASPR2-Antibody, Encephalitis Autoimmune, Paraneoplastic Syndromes
- Trial name
- iniCASPR2 (NCT04653571)
- Testing
- CASPR2 encephalitis
- Where
- France
- Volunteers
- 48 people
- Sponsor
- Hospices Civils de Lyon
Focal Cortical Dysplasia, Epilepsy
Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia
Focal cortical dysplasia (FCD) is a common finding in epilepsy surgery in pediatric patients. Children with intractable epilepsy would have extensive tests to identify the cause of epilepsy; this includes MR brain, video EEG and…
- Trial name
- FCP (NCT00687024)
- Testing
- Magnetoencephalography, MR imaging, Diffusion Tensor Imaging
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- The Hospital for Sick Children
Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis
National Registry of Rare Kidney Diseases
The goal of this National Registry is to is to collect information from patients with rare kidney diseases, so that it that can be used for research.
- Conditions
- Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis, AHL Amyloidosis, AL Amyloidosis
- Trial name
- RaDaR (NCT06065852)
- Where
- United Kingdom
- Volunteers
- 35,000 people
- Sponsor
- UK Kidney Association
Partial Drug-resistant Epilepsy
High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery
High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery (ULYS)
- Trial name
- ULYS (NCT02090569)
- Testing
- Functional micro-Doppler Sonography (fmDS)
- Where
- France
- Volunteers
- 3 people
- Sponsor
- Centre Hospitalier St Anne
Autoimmune Encephalitis
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism
Prospective cohort study evaluating FDG PET in 56 patients with confirmed autoimmune encephalitis - based on 2016 Graus criteria, and 2021 paraneoplastic neurological syndromes criteria - at the acute phase, before…
- Trial name
- ENCEPHATAIP (NCT06079294)
- Testing
- FDG PET
- Where
- France
- Volunteers
- 56 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris