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

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NCT05864846

Sponsored by Jazz Pharmaceuticals (industry) · JAZZ — their whole pipeline →.

Phase

Phase 4

Status

Completed

Study type

Interventional

Design

Na · None · Treatment

Enrollment

79actual

Sites

Countries

Canada, Poland, United Kingdom +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-06-29

actual

When the study began enrolling

Primary completion

2026-04-06

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-04-06

actual

The whole study's end, after follow-up

First posted

2023-05-18

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-04-27

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Tuberous Sclerosis Complex Associated Neuropsychiatric Disease

Intervention

Drug: Cannabidiol Oral Solution [Epidiolex] — also filed as Epidiolex

Primary outcomes

what the primary-completion date above is the date OF

Change in the most problematic behavior Numerical Rating Score (NRS) score within the TAND-SQ

measured Baseline, Week 13, Week 26, Week 52

Change in Tuberous Sclerosis Complex Associated Neuropsychiatric Disorders Self-report, Quantified Checklist (TAND-SQ) score

measured Baseline, Week 13, Week 26, Week 52

Change in Aberrant Behavior Checklist (ABC) score

measured Baseline, Week 13, Week 26, Week 52

Change in Child Behavior Checklist (CBCL) score

measured Baseline, Week 26, Week 52

Change in Adult Behavior Checklist (ABCL) score

measured Baseline, Week 26, Week 52

Change in Adult Self-Report (ASR) score

measured Baseline, Week 26, Week 52

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) domains score

measured Baseline, Week 26, Week 52

Change in sleep characteristics using the Children's Sleep Habits Questionnaire (CSHQ)

measured Baseline, Week 26

Change in sleep characteristics using the Pittsburgh Sleep Quality Index (PSQI)

measured Baseline, Week 26

Change in executive function using Behavior Rating Inventory of Executive Function (BRIEF)

measured Baseline, Week 26

Change in caregiver-reported assessment of Quality of Life (QOL) using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)

measured Baseline, Week 26

Change in caregiver-reported assessment of family functioning using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)

measured Baseline, Week 26

Change in assessment of QOL using Pediatric Quality of Life Inventory (PedsQL)

measured Baseline, Week 26

Change in caregiver impression of overall severity of symptoms (behavior and seizure control) using the Caregiver Global Impression of Severity (CareGI-S)