Epileptic Encephalopathy Clinical Trial
Official title:
Cannabidiol in Children With Refractory Epileptic Encephalopathy: A Phase 1 Open Label Dose Escalation Study (CARE-E)
This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy. The dosage of Cannabis Herbal Extract will be gradually increased over a four month time period.
Epileptic Encephalopathies are a group of epilepsies that develop in children. These epilepsies can cause frequent and difficult to control seizures. Because of the ongoing seizures, these epilepsies can also cause cognitive impairment and neurological impairment. In many children with these Epileptic Encephalopathies, seizures are difficult to control with medical treatment, such as anti-convulsants or non-drug treatments like the ketogenic diet (a high fat, adequate-protein, low-carbohydrate diet). This has resulted in a need to find therapies that are effective and better tolerated for children with epileptic encephalopathies. There is very limited data regarding the use of cannabis products in children, in particular cannabidiol-enriched cannabis oil in children with epilepsy. However, hemp oil products with high cannabidiol and low tetrahydrocannabinol ratios have been reported to provide seizure relief and cognitive improvement in children who take them. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01858285 -
Genetics of Epilepsy and Related Disorders
|
||
Recruiting |
NCT04802135 -
Creation of a Register of Patients With Neonatal-onset Epileptic Encephalopathy
|
||
Terminated |
NCT03955432 -
Long-term Cardiac Monitoring in Epilepsy
|
N/A | |
Recruiting |
NCT05722990 -
Genetic Investigations in Children With Developmental and Epileptic Encephalopathies in Ho Chi Minh City, Vietnam
|
||
Enrolling by invitation |
NCT05301894 -
Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
|
Phase 2 | |
Recruiting |
NCT02603991 -
Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
|
N/A | |
Recruiting |
NCT04496310 -
Tele-epic (Telemedicine for Epilepsy Care)
|
N/A | |
Recruiting |
NCT03934268 -
A Cohort Study on the Prognosis of Neonatal KCNQ2 Gene-associated Epileptic Encephalopathy
|
||
Completed |
NCT04625101 -
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
|
Phase 2 | |
Active, not recruiting |
NCT03936777 -
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
|
Phase 3 |