A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE
NCT07723976 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-07-24
Summary
The efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC). The current JZP926-303 study is being conducted to evaluate the safety and efficacy of CBD-OS in participants with Developmental and Epileptic Encephalopathy (DEE).
Conditions
- Developmental and Epileptic Encephalopathy (DEE)
Interventions
- DRUG
-
CBD-OS
Oral solution, twice daily
- DRUG
-
Oral solution, twice daily
Sponsors & Collaborators
-
Jazz Pharmaceuticals Research UK Limited
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-30
- Primary Completion
- 2029-09-04
- Completion
- 2029-09-04
- FDA Drug
- Yes
More Related Trials
-
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
NCT04485104 ·Status: TERMINATED ·Phase: PHASE3
-
An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes
NCT02224573 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
NCT02224560 ·Status: COMPLETED ·Phase: PHASE3
-
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
NCT02324673 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
NCT06924827 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy
NCT02815540 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
NCT03336242 ·Status: TERMINATED ·Phase: PHASE2
-
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome
NCT02318537 ·Status: WITHDRAWN ·Phase: PHASE3
-
Investigation of Cognitive Outcomes With Cannabidiol Oral Solution
NCT04133480 ·Status: WITHDRAWN ·Phase: PHASE4
-
Cannabidiol for Drug Resistant Pediatric Epilepsy (Expanded Access Use)
NCT03676049 ·Status: AVAILABLE
-
Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy
NCT02660255 ·Status: APPROVED_FOR_MARKETING
-
Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
NCT05485831 ·Status: ACTIVE_NOT_RECRUITING
-
Study of Cannabidiol for Drug-Resistant Epilepsies
NCT03014440 ·Status: NO_LONGER_AVAILABLE
-
Expanded Use of Cannabidiol Oral Solution
NCT03196934 ·Status: NO_LONGER_AVAILABLE
-
Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)
NCT02091375 ·Status: COMPLETED ·Phase: PHASE3
-
Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy
NCT05803434 ·Status: UNKNOWN ·Phase: PHASE2
-
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
NCT02224703 ·Status: COMPLETED ·Phase: PHASE3
-
A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)
NCT02091206 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures
NCT05288283 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
NCT07723963 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
NCT03355300 ·Status: TERMINATED ·Phase: PHASE2
-
Epidiolex® for Anxiety in Pediatric Epilepsy
NCT05324449 ·Status: COMPLETED ·Phase: PHASE4
-
Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome
NCT04611438 ·Status: UNKNOWN ·Phase: PHASE3
-
Epidiolex and Drug Resistant Epilepsy in Children
NCT02397863 ·Status: AVAILABLE
-
Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy
NCT02286986 ·Status: COMPLETED ·Phase: PHASE1