A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorJazz Pharmaceuticals
About this trial
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).
Eligibility criteria
Qualifiers
Is at least 1 year of age at the time of signing the informed consent/assent.
Meets the clinical phenotype for DEE as specified in the protocol.
Per the investigator, the underlying etiology contributes to developmental impairment and seizures.
Has had, or is willing to complete, confirmatory imaging and/or genetic testing to determine etiology of DEE.
Disqualifiers
None
Trial design
Treatments tested in this trial
- CBD-OS
- Placebo
Treatment groups
120 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Research UK Limited
Collaborator
Source ClinicalTrials.gov