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Lennox-Gastaut SyndromePhase 4EpiGOALNCT07728097

A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS

A Phase 4 study testing Cannabidiol Oral Solution in people with Lennox-Gastaut Syndrome, run by Jazz Pharmaceuticals at 3 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lennox-Gastaut Syndrome
What is being tested?
Cannabidiol Oral Solution
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
18 Nov 2026to 28 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a confirmed clinical diagnosis of LGS with a history of seizures and actively experiencing seizures within 6 months of screening.
  • Is naïve to CBD-OS treatment or has been off CBD-OS treatment for at least 3 months prior to screening.
  • Is willing to maintain any factors expected to affect seizures (eg, alcohol consumption, smoking, concomitant medication usage) stable for the duration of the study.
  • Is currently treated with at least 1 ASM, but no more than 3 ASMs, and is on a stable regimen for at least 4 weeks prior to screening.
  • Adequate contraceptive precautions
  • Participant has a primary caregiver/legally authorized representative (LAR) who is willing and able, in the investigator's opinion, to participate throughout the duration of the study and to comply with all study requirements
  • Experienced at least 4 or more countable major motor seizures (isolated seizures or seizures occurring in a cluster) during the 5-week Baseline Period preceding treatment.
  • Caregiver completed at least 80% of seizure diary entries during the Baseline Period with no more than 3 consecutive days of missing entries.

Who cannot join

  • Has a significant psychiatric illness
  • Has an illness during the 4 weeks prior to screening other than epilepsy which, in the investigator's opinion, could affect study outcomes or seizure frequency.
  • Has history of SE in the 3 months prior to screening.
  • Has any other significant disease other than epilepsy, which, in the investigator's opinion, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study.
  • Has previously undergone significant surgery for epilepsy in the 6 months prior to screening or planned to undergo surgery for epilepsy during the study.
  • Is currently using or has in the past used recreational or medicinal cannabis or synthetic cannabinoid-based medications, products, or supplements within the 3 months prior to screening and is not willing to undergo a 1-month washout period before being rescreened.
Show all 15Show fewer
  • Has initiated felbamate within the 12 months prior to screening.
  • Is not willing to adjust dosage of CBD-OS if needed when using strong inducers of CYP3A4 and/or strong inducers of CYP2C19 concomitantly with CBD-OS
  • Previously discontinued cannabidiol due to severe adverse events (SAE), hypersensitivity or lack of efficacy
  • Has clinically significant abnormal lab values
  • Has clinically impaired hepatic or renal function
  • History of, current risk or presence of actual suicidal ideations
  • Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of CBD-OS, such as sesame oil.
  • Has a known or suspected history of alcohol or substance abuse disorder
  • Is currently consuming, and unwilling to stop consumption, or planning to consume tonic water on a regular basis throughout the study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Disclosure & Transparency contact

215-832-3750

ClinicalTrialDisclosure@JazzPharma.com

United States3 sites

  • Neuro Pain Research Center

    Fresno, California, 93722

  • Louisiana State University Health Sciences Center New Orleans

    New Orleans, Louisiana, 70112

  • Velocity Clinical Research At Raleigh Neurology

    Raleigh, North Carolina, 27607

Other trials in United States

About this study

Official title: A Phase 3b/4, Interventional, Prospective, Multicenter, Open-Label Study Evaluating the Effectiveness of a Gradual Titration Regimen to Optimize CBD-OS as Add-On Therapy in Adults With Lennox-Gastaut Syndrome

This is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults.

Being tested
Cannabidiol Oral Solution
Keywords
LGS, Cannabidiol, CBD-OS, Epidiolex, Epidyolex
Medical subject headings
Lennox Gastaut Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabidiol Oral SolutionDrug

    Also called JZP926, CBD-OS, Epidiolex, Epidyolex

    100 mg/ml Cannabidiol Oral solution (CBD-OS)

Study groups in NCT07728097
Study groupRoleWhat they receive
Cannabidiol Oral Solution Treatment groupExperimentalParticipants who will receive the Cannabidiol Oral Solution (CBD-OS) titrated up to a dose of 20 mg/kg per day or the maximum tolerated dose for 24 consecutive weeks.
Receives: Drug: Cannabidiol Oral Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants reporting 50% or more reduction in their 28-day average countable major motor seizure frequency

    Measured: End of Treatment Period, Week 24

Secondary outcomes (25)

  1. Retention Rate

    Retention Rate is defined as percentage of participants completing or continuing CBD-OS treatment at different timepoints in the study

    Measured: At Weeks 8, 12, 16 and 24

  2. Percentage of participants experiencing worsening, change, no change or improvement in in their 28-day average countable major motor and total seizure frequency

    As reported in participants' electronic diaries

    Measured: Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24

  3. Percentage of participants considered treatment responders

    Treatment responders will be categorized as those experiencing a 50% or more reduction, a 75% or more reduction or 100% reduction in their 28-day average seizure frequency as reported in participants' electronic diaries

    Measured: Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24

  4. Change in 28-day average frequency of countable major motor and total seizures

    Assessed per 28 days from electronic diary entries

    Measured: Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24

  5. Change in number of seizure-free days

    Assessed per 28 days from electronic diary entries

    Measured: Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24

  6. Change in CaGI-S severity of seizure scores

    Caregiver Global Impression of Severity (CaGI-S) is a single-item, 5-point Likert-type rating scale (ranging from 0 "not severe at all" to 5 "very severe"). Using this scale, caregivers will be asked to rate their impression of the participant's severity of seizures, and the severity of the impact caused by the seizure.

    Measured: Baseline to Week 16, Baseline to Week 24

  7. Change in CaGI-S severity of impact of seizures scores

    Caregiver Global Impression of Severity (CaGI-S) is a single-item, 5-point Likert-type rating scale (ranging from 0 "not severe at all" to 5 "very severe"). Using this scale, caregivers will be asked to rate their impression of the participant's severity of the impact caused by the seizure.

    Measured: Baseline to Week 16, Baseline to Week 24

  8. Change in VAS scores

    Visual Analog Scale (VAS) is a caregiver-reported tool used to quantify the severity of impact of subjective non-seizure symptoms and assesses sleep, communication, and disruptive behavior. The VAS enables sensitive detection of changes in non-seizure domains (disruptive behavior, Sleep, and Communication) important to patients with LGS and their caregivers. The VAS has a total score ranging from 0 to 100 with the higher score indicating worse conditions.

    Measured: Baseline to Week 16, Baseline to Week 24

  9. Change in CaGI-S severity of level of alertness scores

    CaGI-S Alertness is a caregiver single item assessment on a 5-point Likert-type rating scale (ranging from 0 "not severe at all" to 5 "very severe") assessing their impression of participant's severity of level of awareness

    Measured: Baseline to Week 16, Baseline to Week 24

  10. Change in CaGI-S severity of overall condition scores

    CaGI-S Overall Condition is a caregiver single item assessment on a 5-point Likert-type rating scale (ranging from 0 "not severe at all" to 5 "very severe") assessing their impression of participant's severity of overall condition

    Measured: Baseline to Week 16, Baseline to Week 24

  11. CaGI-C level of alertness scores

    Caregiver Global Impression of Change (CaGI-C) Alertness is a caregiver single item assessment on a 7-point Likert-type rating scale (ranging from 1 "very much improved" to 7 "very severe") assessing their impression of participant's severity of level of awareness

    Measured: At Week 16, at week 24

  12. CaGI-C overall condition scores

    Caregiver Global Impression of Change (CaGI-C) overall condition is a caregiver single item assessment on a 7-point Likert-type rating scale (ranging from 1 "very much improved" to 7 "very severe") assessing their impression of participant's severity of overall condition

    Measured: At Week 16, at week 24

  13. Change in CGI-S overall condition scores

    Clinician Global Impression of severity (CGI-S) Overall Condition is a clinician single item assessment on a 5-point Likert-type rating scale (ranging from 1 "not severe at all" to 5 "very severe") assessing their impression of participant's severity of level of overall condition

    Measured: Baseline to Week 16, Baseline to Week 24

  14. CGI-C overall condition scores

    Clinician Global Impression of Change (CGI-C) Overall Condition is a clinician single item assessment on a 7-point Likert-type rating scale (ranging from 1 "very much improved" to 5 "very much worse") assessing their impression of participant's change of overall condition

    Measured: At Week 16, At Week 24

  15. Change in ELDQOL Behavior subscale scores

    Epilepsy and Learning Disabilities Quality of Life (ELDQOL) is designed for the caregiver to rate the quality of life (QOL) in children with severe epilepsy and learning disabilities over the last month. The questionnaire has a total of 28 main questions, grouped into 4 subscales: behavior, seizure severity, mood, and side effects. The ELDQOL behavior subscale includes 9 of the 28 total main questions with a total score ranging from 9 to 36 with the higher score indicating greater behavioral problems

    Measured: Baseline to Week 16, Baseline to Week 24

  16. Change in ELDQOL seizure severity subscale scores

    Epilepsy and Learning Disabilities Quality of Life (ELDQOL) is designed for the caregiver to rate the quality of life (QOL) in children with severe epilepsy and learning disabilities over the last month. The questionnaire has a total of 28 main questions, grouped into 4 subscales: behavior, seizure severity, mood, and side effects. The ELDQOL seizure severity subscale includes 14 of the 28 total main questions with a total score ranging from 10 to 56 with the higher score indicating greater seizure severity

    Measured: Baseline to Week 16, Baseline to Week 24

  17. Change in ELDQOL mood scale subscale scores

    Epilepsy and Learning Disabilities Quality of Life (ELDQOL) is designed for the caregiver to rate the quality of life (QOL) in children with severe epilepsy and learning disabilities over the last month. The questionnaire has a total of 28 main questions, grouped into 4 subscales: behavior, seizure severity, mood, and side effects. The ELDQOL mood scale subscale includes 1 of the 28 total questions with a total score ranging from 16 to 64 with the higher score indicating greater mood problems

    Measured: Baseline to Week 16, Baseline to Week 24

  18. Change in ELDQOL side-effects profile subscale scores

    Epilepsy and Learning Disabilities Quality of Life (ELDQOL) is designed for the caregiver to rate the quality of life (QOL) in children with severe epilepsy and learning disabilities over the last month. The questionnaire has a total of 28 main questions, grouped into 4 subscales: behavior, seizure severity, mood, and side effects. The ELDQOL side-effects profile subscale includes 2 of the 28 total main questions with a score ranging from 19 to 76 with the higher score indicating greater side effects

    Measured: Baseline to Week 16, Baseline to Week 24

  19. Number of participants reporting adverse events leading to discontinuation

    Measured: Up to week 24

  20. Time the adverse events started from baseline

    Measured: Up to week 24

  21. Number of Participants with Abnormal Laboratory Values

    Measured: Up to week 24

  22. Change in suicidal ideation scores

    As evaluated by the Columbia-Suicide Severity Rating Scale (C-SSRS). The questionnaire has a total score ranging from 0 to 5 with a score of 0 indicating no suicidal ideation is present.

    Measured: Baseline, up to week 24

  23. Change in number of suicide attempts

    As per the response in the C-SSRS

    Measured: Baseline, up to week 24

  24. Percentage of participants requiring inpatient hospitalization due to epilepsy

    Measured: Up to week 24

  25. Change in number of usage of rescue medication

    Measured: Baseline, Up to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start18 Nov 2026 (estimated)
  3. Primary completion28 Dec 2028 (estimated)
  4. Study completion28 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07728097
Sponsor's protocol ID
JZP926-403
Acronym
EpiGOAL
Status last verified
Oct 2026
First submitted
22 Jul 2026
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cannabidiol Oral Solution in people with Lennox-Gastaut Syndrome, run by Jazz Pharmaceuticals at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants reporting 50% or more reduction in their 28-day average countable major motor seizure frequency (time frame: End of Treatment Period, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07728097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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