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

NCT07728097 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: JZP926-403
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lennox-Gastaut Syndrome

Keywords

LGS; Cannabidiol; CBD-OS; Epidiolex; Epidyolex

Outcome Measures

Primary Outcomes (1)

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

  End of Treatment Period, Week 24

Secondary Outcomes (25)

• Retention Rate

  At Weeks 8, 12, 16 and 24

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

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

• Percentage of participants considered treatment responders

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

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

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

• Change in number of seizure-free days

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

Study Arms (1)

Cannabidiol Oral Solution Treatment group

EXPERIMENTAL

Participants 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.

Drug: Cannabidiol Oral Solution

Interventions

Cannabidiol Oral Solution DRUG

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

Also known as: JZP926, CBD-OS, Epidiolex, Epidyolex

Cannabidiol Oral Solution Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Louisiana State University Health Sciences Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Lennox Gastaut Syndrome

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Epileptic Syndromes; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): November 18, 2026
• Primary Completion (Estimated): December 28, 2028
• Study Completion (Estimated): December 28, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)