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Not yet recruitingNCT07723976Updated Jul 24, 2026

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

A Phase 3 interventional study of CBD-OS and Placebo in Developmental and Epileptic Encephalopathy (DEE), sponsored by Jazz Pharmaceuticals. Not yet recruiting. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Jazz Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
1 Year and older
Sex
All
01

Study 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).

Read the detailed description

This Phase 3, multicenter, randomized, placebo-controlled, double-blind study will evaluate the efficacy and safety of CBD-OS in participants aged ≥ 1 year with DEE. The primary objective of the 6-week Double-blind Treatment Period of the study is to assess the efficacy of CBD-OS in reducing the frequency of countable motor seizures compared with placebo in participants with DEE. In addition, the Double-Blind Treatment Period will also assess the safety and tolerability of CBD-OS. The optional 6-month open-label extension (OLE) will provide additional data on the long-term efficacy, safety, and tolerability of CBD-OS.

02

Conditions studied

  • Developmental and Epileptic Encephalopathy (DEE)

Keywords

  • Developmental and Epileptic Encephalopathy
  • JZP926-OS
  • CBD-OS
03

In context

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    CBD-OS

    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 comparator
    Placebo

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

    Drug: Placebo

  • Experimental
    Open-Label Extension: CBD-OS

    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

  • DrugCBD-OS

    Oral solution, twice daily

    Also known as: JZP926-OS

  • DrugPlacebo

    Oral solution, twice daily

06

What researchers measure

Primary outcomes

  1. Change in Countable Motor Seizure Frequency Per 28 Days

    Time frame: Baseline up to 6 weeks of double-blind treatment period

Secondary outcomes

  1. Change in Total Seizure Frequency Per 28 Days

    Time frame: Baseline up to 6 weeks of double-blind treatment period

  2. Proportion of Participants Who Achieve ≥ 50% Reduction From Baseline in Countable Motor Seizure Frequency

    Time frame: Baseline up to 6 weeks of double-blind treatment period

  3. Caregiver Global Impression of Change (CaGI-C) Score

    Time frame: Week 6 of double-blind treatment period

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

    Time frame: Week 6 of double-blind treatment period

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

    Time frame: Baseline up to 6 weeks of double-blind treatment period

  6. Clinical Global Impression of Change (CGI-C) Score

    Time frame: Week 6 of double-blind treatment period

  7. Change from Baseline in Clinical Global Impression of Severity (CGI-S) Score

    Time frame: Week 6 of double-blind treatment period

  8. Number of Participants Reporting Treatment-emergent Adverse Events

    Time frame: Baseline up to 6 weeks of double-blind treatment period

  9. Mean Plasma Concentration of CBD

    Time frame: Baseline up to 6 weeks of double-blind treatment period

  10. Mean Plasma Concentration of Metabolite 7-OH-CBD

    Time frame: Baseline up to 6 weeks of double-blind treatment period

  11. Mean Plasma Concentration of Metabolite 7-COOH-CBD

    Time frame: Baseline up to 6 weeks of double-blind treatment period

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07723976
Lead sponsor
Jazz Pharmaceuticals
Collaborators
Jazz Pharmaceuticals Research UK Limited
Responsible party
Sponsor
First posted
Jul 23, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Sep 4, 2029 (estimated)
Completion
Sep 4, 2029 (estimated)
Last update
Jul 24, 2026

Study contacts

Clinical Trial Disclosure & Transparency
Contact
ClinicalTrialDisclosure@JazzPharma.com
215-832-3750

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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