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NCT05044819 · ClinicalTrials.gov registry record · Phase 4
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution
A Phase 4 study of Dravet Syndrome and Lennox Gastaut Syndrome, sponsored by Jazz Pharmaceuticals.
- Active
- Registry status
- Phase 4
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT05044819: Active Phase 4 study of Dravet Syndrome and Lennox Gastaut Syndrome, sponsored by Jazz Pharmaceuticals.
NCT05044819 is a Phase 4 study of Dravet Syndrome and Lennox Gastaut Syndrome that is active but no longer recruiting, run by Jazz Pharmaceuticals. The registered enrollment target is 154 participants, above the 97-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (59% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05044819, a Phase 4 study of Dravet Syndrome and Lennox Gastaut Syndrome, is active but no longer recruiting, sponsored by Jazz Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.
Conditions Studied
Interventions
- DRUG Cannabidiol
Study Locations (20)
Florida
- Clinical Trial Site - Miami
- Clinical Trial Site - Miami
- Clinical Trial Site - Orlando
- Clinical Trial Site - Tampa
California
- Clinical Trial Site - Downey
- Clinical Trial Site - Long Beach
- Clinical Trial Site - Sacramento
North Carolina
- Clinical Trial Site - Charlotte
- Clinical Trial Site - Durham
Arkansas
- Clinical Trial Site - Little Rock
Georgia
- Clinical Trial Site - Augusta
Kansas
- Clinical Trial Site - Wichita
Kentucky
- Clinical Trial Site - Lexington
Maryland
- Clinical Trial Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2021-07-07 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 4 |
What the registry record for NCT05044819 still lists
NCT05044819 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 97-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (59% higher).
The record links to 3 conditions, with Dravet Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Cannabidiol is the first listed.
NCT05044819 names 20 study sites across 14 states, led by Florida, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05044819 about?
NCT05044819 is a clinical study titled "Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution". This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.
What is the current status of trial NCT05044819?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 154 participants. The study started on 2021-07-07. Estimated completion is 2028-03-31.
What conditions does trial NCT05044819 study?
This clinical trial studies the following conditions: Dravet Syndrome, Lennox Gastaut Syndrome, Tuberous Sclerosis Complex.
What interventions are being tested in trial NCT05044819?
The interventions under investigation include: Cannabidiol (DRUG).
Who is sponsoring clinical trial NCT05044819?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05044819 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dravet Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05044819's enrollment target sits among peer trials
154 4th of 12 higher than 9 of 12 other Dravet Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dravet Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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