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
Public ClinicalTrials.gov record NCT05864846. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Interventional, Multicenter, Open-Label, Single-Arm Study to Assess Behavioral and Other Co-occurring Outcomes Following Treatment With EPID(I/Y)OLEX as Add-on Therapy in Participants (Aged 1 to 65 Years Old) With Seizures Associated With Tuberous Sclerosis Complex
Study identification
- NCT ID
- NCT05864846
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- Jazz Pharmaceuticals
- Industry
- Enrollment
- 79 participants
Conditions and interventions
Interventions
- Cannabidiol Oral Solution [Epidiolex] Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Year to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 28, 2023
- Primary completion
- Apr 5, 2026
- Completion
- Apr 5, 2026
- Last update posted
- Apr 26, 2026
2023 – 2026
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | — |
| University of Florida Health - Department of Neurology | Gainesville | Florida | 32608 | — |
| Nicklaus Children's Health, Miami | Miami | Florida | 33155 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Minnesota Epilepsy Group | Roseville | Minnesota | 55113 | — |
| Atrium Health Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | — |
| University of Texas Health Science Center at Houston - Clinical Research Unit | Houston | Texas | 77030 | — |
| University of Texas Health Science Center - San Antonio | San Antonio | Texas | 78229 | — |
| University of Virginia, Charlottesville | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05864846, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2026 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05864846 live on ClinicalTrials.gov.