Tests a gradual dose increase of cannabidiol in adults with Lennox-Gastaut syndrome
Studies cannabidiol oral solution added to usual treatment in adults with Lennox-Gastaut syndrome.
Plain-language title generated from the registry record
Registry title: A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS
Key facts
- Where
- Fresno, New Orleans, and Raleigh, United StatesSee the 3 sites
- Phase
- Phase 4
Where in United States
- Neuro Pain Research CenterFresno, United StatesNo longer taking part
- Louisiana State University Health Sciences Center- New OrleansNew Orleans, United StatesNo longer taking part
- Velocity Clinical Research at Raleigh NeurologyRaleigh, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jazz Pharmaceuticals
- Trial code
- NCT07728097
- Record updated
- 22 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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 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; Has initiated felbamate within the 12 months prior to screening; Previously discontinued cannabidiol due to severe adverse events (SAE), hypersensitivity or lack of efficacy; Has a significant psychiatric illness; 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; 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; Has clinically significant abnormal lab values; 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; Has clinically impaired hepatic or renal function; Is currently consuming, and unwilling to stop consumption, or planning to consume tonic water on a regular basis throughout the study.