A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE

NCT07723976 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: JZP926-303
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Developmental and Epileptic Encephalopathy; JZP926-OS; CBD-OS

Outcome Measures

Primary Outcomes (1)

• Change in Countable Motor Seizure Frequency Per 28 Days

  Baseline up to 6 weeks of double-blind treatment period

Secondary Outcomes (11)

• 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

• Change from Baseline in Caregiver Global Impression of Severity (CaGI-S) Score

  Week 6 of double-blind treatment period

• Change From Baseline in Number of Countable Motor Seizure-free Days per 28 Days

  Baseline up to 6 weeks of double-blind treatment period

Study Arms (3)

CBD-OS

EXPERIMENTAL

Participants with DEE will be randomized to CBD-OS up to 10 mg/kg twice daily for a 6-week treatment period.

Drug: CBD-OS

Placebo

PLACEBO COMPARATOR

Participants with DEE will be randomized to matching placebo for a 6-week treatment period.

Drug: Placebo

Open-Label Extension: CBD-OS

EXPERIMENTAL

Participants 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.

Drug: CBD-OS

Interventions

Placebo DRUG

Oral solution, twice daily

Placebo

CBD-OS DRUG

Oral solution, twice daily

Also known as: JZP926-OS

CBD-OS; Open-Label Extension: CBD-OS

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 contributes to developmental impairment and seizures. 4. Has had, or is willing to complete, confirmatory imaging and/or genetic testing to determine etiology of DEE. 5. Is currently receiving antiseizure intervention, such as treatment with a stable regimen of at least 1 ASM or an established intervention for epilepsy (eg, ketogenic diet or neurostimulation). 6. All medications or interventions for epilepsy have been stable for ≥ 28 days prior to starting the baseline period (Visit 2) with no planned changes to the regimen for the duration of the Double-blind Treatment Period. Participants are excluded from the study if any of the following criteria apply: 1. Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the efficacy measures, in the opinion of the investigator. 2. The etiology of the participant's seizures is a progressive neurologic disease. 3. Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention, such as sesame oil. 4. Has an active central nervous system (CNS) infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the study that may confound the interpretation of the study results (including autoimmune encephalitis). 5. Is currently being treated with Epidiolex or recently received treatment with Epidiolex within 28 days prior to screening. 6. Has experienced a lack of efficacy and/or poor tolerability to an adequate treatment regimen of Epidiolex based on medical history and the clinical judgement of the investigator. Participants who discontinued treatment for reasons other than safety, tolerability, or lack of efficacy and previously received Epidiolex ≥ 28 days prior to starting the Baseline Period (Visit 2) may be eligible for the study after consultation with the medical monitor and/or sponsor representative. 7. Has been taking felbamate for less than 12 months prior to screening. Participants who are stable on felbamate for ≥ 12 months are eligible for inclusion.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Jazz Pharmaceuticals Research UK Limited: collaborator

Central Study Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): September 4, 2029
• Study Completion (Estimated): September 4, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share