A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS
Part of paid clinical trials in New Orleans, Louisiana.
- Sponsor
- Jazz Pharmaceuticals
- Study ID
- NCT07728097
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Lennox-Gastaut Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cannabidiol Oral Solution — DRUG100 mg/ml Cannabidiol Oral solution (CBD-OS)
Study Details
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.
Key Dates
- First listed
- Jul 27, 2026
- Start date
- Nov 18, 2026
- Status verified
- Jul 2026
- Primary completion
- Dec 28, 2028
- Completion
- Dec 28, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cannabidiol Oral Solution Treatment groupParticipants 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.
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 ]
Central Contacts
- Clinical Trial Disclosure & Transparency215-832-3750
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Louisiana State University Health Sciences Center New Orleans | New Orleans | Louisiana | 70112 | - |