Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05044819
The ClinicalTrials.gov registry entry for NCT05044819 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 97-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (59% higher). The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
-
A Double-blind Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen in Patients With Dravet Syndrome
RECRUITING · Phase 3
-
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
RECRUITING · Phase 1
-
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
RECRUITING · Phase 3
-
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
RECRUITING · Phase 3
-
GABA Biomarkers in Dravet Syndrome
RECRUITING
-
An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome
ACTIVE NOT RECRUITING · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.