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CBD-OS

Phase 3

Developmental and Epileptic Encephalopathy (DEE) | Small molecule | Other |Jazz Pharmaceuticals plc|Last Updated: Jul 24, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical trial landscape

CBD-OS · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT07723976A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEEDevelopmental and Epileptic Encephalopathy (DEE)
NOT YET_RECRUITING120 Analytics
PHASE3NOT YET_RECRUITING
A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE
Developmental and Epileptic Encephalopathy (DEE)
NCT07723976120
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Study Endpoints
Primary Endpoints
Change in Countable Motor Seizure Frequency Per 28 Days
Baseline up to 6 weeks of double-blind treatment period
Percent change in countable focal seizure frequency compared to baseline
Baseline up to 16 weeks
Secondary Endpoints
Change in Total Seizure Frequency Per 28 Days
Baseline up to 6 weeks of double-blind treatment period
Proportion of Participants Who Achieve ≥ 50% Reduction From Baseline in Countable Motor Seizure Frequency
Baseline up to 6 weeks of double-blind treatment period
Caregiver Global Impression of Change (CaGI-C) Score
Week 6 of double-blind treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CBD-OSEXPERIMENTALParticipants with DEE will be randomized to CBD-OS up to 10 mg/kg twice daily for a 6-week treatment period.
PlaceboPLACEBO_COMPARATORParticipants with DEE will be randomized to matching placebo for a 6-week treatment period.
Open-Label Extension: CBD-OSEXPERIMENTALParticipants with DEE who completed the double-blind phase of the study and enter the optional OLE will begin a 22-week open-label treatment period with CBD-OS up to 10 mg/kg twice daily following a 2-week Blinded Transition Period.
Interventions
NameTypeDescription
CBD-OSDRUGOral solution, twice daily
PlaceboDRUGOral solution, twice daily
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Eligibility Criteria
Age Range1 Year to N/A
SexALL
Healthy VolunteersNo

Participants are eligible to be included in the study only if all the following criteria apply: 1. Is at least 1 year of age at the time of signing the informed consent/assent. 2. Meets the clinical phenotype for DEE as specified in the protocol. 3. Per the investigator, the underlying etiology con...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJul 24, 2026NCT07723976NEW_TRIAL: changed
LOWJul 24, 2026NCT07723976NEW_TRIAL: changed
LOWJun 9, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 9, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 9, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 9, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWMay 26, 2026NCT07233239primaryCompletionDate: changed
LOWMay 24, 2026NCT07233239studyFirstPostDate: changed