Trials / Active Not Recruiting
Active Not RecruitingNCT05864846
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, 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
- Status
- Active Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Year – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cannabidiol Oral Solution [Epidiolex] | 100 mg/ml Cannabidiol Oral solution |
Timeline
- Start date
- 2023-06-29
- Primary completion
- 2026-03-26
- Completion
- 2026-03-26
- First posted
- 2023-05-18
- Last updated
- 2026-03-12
Locations
19 sites across 4 countries: United States, Canada, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05864846. Inclusion in this directory is not an endorsement.