Epilepsy Clinical Trial
Official title:
A Phase 3 Study of Adjunctive XEN496 in Pediatric Subjects With KCNQ2 Developmental and Epileptic Encephalopathy
To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).
The EPIK Phase 3 clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study targeting to enroll approximately 40 pediatric subjects (aged from 1 month to less than 6 years) with documented genetic evidence consistent with a diagnosis of KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE). After screening, subjects will enter a baseline period before being randomized to receive either XEN496 (ezogabine) or placebo, added to their existing antiseizure medications (ASMs), for 12 weeks (maintenance), once a titration period of up to 24 days is complete. At the end of the maintenance phase, eligible subjects will have the opportunity to qualify for and participate in the separate open-label extension (OLE) study and receive XEN496 or, should they choose to exit the study, will undergo a dose taper period of up to 15 days and 4-week follow-up. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04595513 -
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
|
Phase 1/Phase 2 | |
| Completed |
NCT02909387 -
Adapting Project UPLIFT for Blacks in Georgia
|
N/A | |
| Completed |
NCT05552924 -
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
|
N/A | |
| Terminated |
NCT01668654 -
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
|
Phase 3 | |
| Not yet recruiting |
NCT05068323 -
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
|
N/A | |
| Completed |
NCT03994718 -
Creative Arts II Study
|
N/A | |
| Recruiting |
NCT04076449 -
Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
|
||
| Completed |
NCT00782249 -
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
|
N/A | |
| Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
| Recruiting |
NCT05101161 -
Neurofeedback Using Implanted Deep Brain Stimulation Electrodes
|
N/A | |
| Active, not recruiting |
NCT06034353 -
Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
|
N/A | |
| Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
| Not yet recruiting |
NCT06408428 -
Glioma Intraoperative MicroElectroCorticoGraphy
|
N/A | |
| Not yet recruiting |
NCT05559060 -
Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
|
||
| Completed |
NCT02977208 -
Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use
|
Phase 4 | |
| Completed |
NCT02646631 -
Behavioral and Educational Tools to Improve Epilepsy Care
|
N/A | |
| Completed |
NCT02952456 -
Phenomenological Approach of Epilepsy in Patients With Epilepsy
|
||
| Recruiting |
NCT02539134 -
TAK-935 Multiple Rising Dose Study in Healthy Participants
|
Phase 1 | |
| Terminated |
NCT02757547 -
Transcranial Magnetic Stimulation for Epilepsy
|
N/A | |
| Completed |
NCT02491073 -
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
|
N/A |