Can a slow start with CBD oil tame Hard-to-Control seizures?
NCT ID NCT07728097
First seen Jul 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times
Summary
This trial tests whether a gradual dosing schedule of cannabidiol oral solution (CBD-OS) can help reduce seizures in adults with Lennox-Gastaut syndrome, a severe form of epilepsy. Participants will take CBD oil alongside their usual seizure medications. The study measures how many people experience at least a 50% drop in major motor seizures over 28 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cannabidiol oral solution (CBD-OS), a purified CBD oil taken by mouth
- What this could lead to
- If successful, this could offer a better-tolerated way to add CBD to existing seizure medications for adults with Lennox-Gastaut syndrome.
- What could go wrong
- This is an open-label trial with no placebo group, so results may be less reliable. CBD can cause side effects like drowsiness, diarrhea, and liver enzyme changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Has a confirmed clinical diagnosis of LGS with a history of seizures and actively experiencing seizures within 6 months of screening. 2. Is naïve to CBD-OS treatment or has been off CBD-OS treatment for at least 3 months prior to screening. 3. Is willing to maintain any factors expected to affect seizures (eg, alcohol consumption, smoking, concomitant medication usage) stable for the duration of the study. 4. 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. 5. Adequate contraceptive precautions 6. 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 7. 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. 8. Caregiver completed at least 80% of seizure diary entries during the Baseline Period with no more than 3 consecutive days of missing entries. Exclusion Criteria: 1. Has a significant psychiatric illness 2. 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. 3. Has history of SE in the 3 months prior to screening. 4. 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. 5. Has previously undergone significant surgery for epilepsy in the 6 months prior to screening or planned to undergo surgery for epilepsy during the study. 6. 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. 7. Has initiated felbamate within the 12 months prior to screening. 8. 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 9. Previously discontinued cannabidiol due to severe adverse events (SAE), hypersensitivity or lack of efficacy 10. Has clinically significant abnormal lab values 11. Has clinically impaired hepatic or renal function 12. History of, current risk or presence of actual suicidal ideations 13. Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of CBD-OS, such as sesame oil. 14. Has a known or suspected history of alcohol or substance abuse disorder 15. Is currently consuming, and unwilling to stop consumption, or planning to consume tonic water on a regular basis throughout the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana, 70112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug curb seizures in children with severe epilepsy?
- Which treatment tames LGS seizures better: surgery or more meds?
- Lifeline for kids with severe epilepsy: drug access extended
- Brain pacemaker shows promise for rare childhood epilepsy
- Brain implant shows promise for Hard-to-Treat seizures in rare epilepsy
- New drug shows promise for rare, severe childhood epilepsy