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

Jazz Pharmaceuticals

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 pr…

Interventions

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

Location

Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions