Phase 2 N=20 Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC)
Epilepsy · Tuberous Sclerosis Complex
Primary: Reduction in Seizure Frequency — 60 percentage
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=84 Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex
Tuberous Sclerosis Complex
Primary: Cognitive Assessment Scores and Developmental Impact — 83.9; 80.9; 97.3; 85.0 score on a scale — p=0.8681
Phase 3 N=366 A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
Tuberous Sclerosis Complex-associated Refractory Seizures
Primary: Core Phase: European Medicine Agency (EMA): Seizure Frequency Response Rate — 28.2; 40.0; 15.1 Percentage of responders — p=0.008
Phase 2 N=15 A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD
Epilepsy · Tuberous Sclerosis Complex · Focal Cortical Dysplasia
Primary: Number of Patients With Adverse Events — 0; 0 Participants
Phase 2 N=47 Trial of RAD001 and Neurocognition in Tuberous Sclerosis Complex (TSC)
Tuberous Sclerosis Complex
Primary: Evaluation of the Safety of RAD001 on Neurocognition in Patients With TSC Compared With Placebo in Patients With TSC. — 325; 147 Adverse Events
Phase 2 N=5 Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
Tuberous Sclerosis Complex · Epilepsy
Primary: Safety - Adverse Events — 40 percentage of participants
Phase 3 N=224 A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Tuberous Sclerosis Complex · Seizures
Primary: Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration) — -43.36…
Phase 3 N=240 RNS® System Pivotal Study
Epilepsy
Primary: Acute SAE Rate — 12.0 percentage of subjects with ≥ 1 SAE
Phase 3 N=356 Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
Epilepsy
Primary: Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase — -23.25; -9.80 Percentage change
Phase 2 N=23 Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B)
Tuberous Sclerosis
Primary: Percent Change From Baseline in 28-day Seizure Frequency Through the End of 12-Week Treatment Period — -16.61 Percent change
N/A N=11 Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
Epilepsies, Partial
Primary: 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment — 0; 0; 0; 0 participants
Phase 3 N=539 Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
Seizures
Primary: Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)…
Phase 3 N=132 A Study With SAGE-547 for Super-Refractory Status Epilepticus
Super-Refractory Status Epilepticus
Primary: Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥…
Phase 3 N=52 Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
Seizures
Primary: Percentage of Participants With Adverse Events — 88.9; 92.3; 88.2; 90.4 Percentage of participants
Phase 3 N=306 Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
Seizures
Primary: Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)…
Phase 2 N=7 Thalidomide Low Threshold in Epilepsy
Refractory Epilepsy
Primary: Change From Baseline in the Mean Number of Daily Seizures at 1 Year. — 9 Number of Seizures — p=<0.02
Phase 3 N=117 Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)
Tuberous Sclerosis · Subependymal Giant Cell Astrocytoma
Primary: Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response — 34.6; 0.0; 57.7 Percentage of participants
Phase 2 N=25 Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
Super-refractory Status Epilepticus
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 17; 6 Participants
Phase 3 N=249 Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Epilepsy
Primary: Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. — 39.5; 21.65 Percent…
Phase 4 N=230 RNS® System LTT Study
Epilepsy
Primary: Number of Participants With Serious Adverse Events (SAE) — 177 Participants
Phase 2 N=28 Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex
Tuberous Sclerosis · Subependymal Giant Cell Astrocytoma
Primary: Number With Observed Adverse Side Effects — 26; 25; 15; 14 participants
Phase 2 N=3 Rapalogues for Autism Phenotype in TSC: A Feasibility Study
Tuberous Sclerosis Complex · Self-injury · Autism
Primary: Number of Participants With Compliance to the Treatment Protocol. — 100; 58; 58 percentage of completed visits/measures
Phase 2 N=5 Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome
Sturge-Weber Syndrome
Primary: Number of Seizures Per Month — 33.5; 30.0; 3.0; 0.5 Seizures per month
Phase 3 N=304 Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Partial Epilepsy in Children and Adolescents
Primary: Change From Baseline in Seizure Frequency — 62.0; 36.6 seizures/month — p=0.2490
N/A N=22 Transcranial Magnetic Stimulation for BECTS
Benign Epilepsy With Centrotemporal Spikes · Language Problems · Learning Disorders
Primary: Interictal Epileptiform Discharge (IED) Frequency — 0; 0; 0; 0 IEDs per 5 minutes — p=0.04
N/A N=5 Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
Epilepsy, Temporal Lobe
Primary: Self-reported Seizure Frequency — 6.4 seizure days per 4 weeks
Phase 3 N=129 Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy
Tuberous Sclerosis Complex
Primary: Percent Change From Baseline in 28-day Seizure Frequency for Primary Seizure Type During Double Blind Period — -7.50; 13.57 Percent change — p=0.0904
Phase 4 N=343 Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Epilepsy
Primary: Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational…
Phase 2 N=30 Everolimus for Cancer With TSC1 or TSC2 Mutation
TSC1 · TSC2 · Tuberous Sclerosis Complex
Primary: Objective Response Rate — 2 Participants
Phase 3 N=240 Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
Partial Seizures
Primary: Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures…