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NCT05864846 · ClinicalTrials.gov registry record · Phase 4
A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex
A Phase 4 study of Tuberous Sclerosis Complex Associated Neuropsychiatric Disease, sponsored by Jazz Pharmaceuticals.
- Active
- Registry status
- Phase 4
- Development phase
- 79
- Enrollment target
- 19
- Study locations
NCT05864846: Active Phase 4 study of Tuberous Sclerosis Complex Associated Neuropsychiatric Disease, sponsored by Jazz Pharmaceuticals.
NCT05864846 is a Phase 4 study of Tuberous Sclerosis Complex Associated Neuropsychiatric Disease that is active but no longer recruiting, run by Jazz Pharmaceuticals. The registered enrollment target is 79 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). The trial reports 19 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05864846, a Phase 4 study of Tuberous Sclerosis Complex Associated Neuropsychiatric Disease, is active but no longer recruiting, sponsored by Jazz Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 79 participants
- Enrollment target
- 19
- Study locations
Study Summary
The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.
Conditions Studied
Interventions
- DRUG Cannabidiol Oral Solution [Epidiolex]
Study Locations (19)
Other
- The Children's Memorial Health Institute - Warsaw
- University Hospitals Bristol NHS Foundation Trust - Bristol
- Sheffield Children's NHS Foundation Trust - Sheffield
Florida
- University of Florida Health - Department of Neurology - Gainesville
- Nicklaus Children's Health, Miami - Miami
Texas
- University of Texas Health Science Center at Houston - Clinical Research Unit - Houston
- University of Texas Health Science Center - San Antonio - San Antonio
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Yale University School of Medicine - New Haven
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Minnesota Epilepsy Group - Roseville
North Carolina
- Atrium Health Wake Forest Baptist Medical Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2023-06-29 |
| Est. Completion | 2026-03-26 |
| Phase | Phase 4 |
What the registry record for NCT05864846 still lists
NCT05864846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Tuberous Sclerosis Complex Associated Neuropsychiatric Disease appearing as the primary indexed condition, and to 1 intervention - of which Cannabidiol Oral Solution [Epidiolex] is the first listed.
NCT05864846 lists 19 locations in 15 states (Other, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT05864846 about?
NCT05864846 is a clinical study titled "A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex". The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.
What is the current status of trial NCT05864846?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 79 participants. The study started on 2023-06-29. Estimated completion is 2026-03-26.
What conditions does trial NCT05864846 study?
This clinical trial studies the following conditions: Tuberous Sclerosis Complex Associated Neuropsychiatric Disease.
What interventions are being tested in trial NCT05864846?
The interventions under investigation include: Cannabidiol Oral Solution [Epidiolex] (DRUG).
Who is sponsoring clinical trial NCT05864846?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05864846 being conducted?
This trial has 19 study locations across Colorado, Connecticut, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05864846's enrollment target sits among peer trials
79 980th of 2000 higher than 1,020 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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