Trial · NCT05485831
Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
NCT05485831, Active not recruiting, Jazz Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY. Trials, record NCT05485831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05485831
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
- NCT number
- NCT05485831
- Status
- Active not recruiting
- Enrollment
- 111 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex
- Interventions
- Epidiolex 100 mg/mL Oral Solution
- First posted
- 2022-08-03
- Last updated
- 2026-06-03
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Remaining on Therapy from Enrollment | Baseline up to Week 52 post-dose. | Treatment retention will be evaluated through the proportion of participants remaining on therapy from the enrollment visit (baseline, V0) to each study visit (Weeks 4 \[V1\], 16 \[V2\], 28 \[V3\], 40 \[V4\], 52 \[V5\]). |
| Secondary | Average Number of Seizure-Free Days in the Last 28 Days | Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5) | |
| Secondary | Longest Duration of Seizure Free Days in the Last 28 Days | Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5) | |
| Secondary | Average Maintenance Dose of Epidyolex® | Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5) | |
| Secondary | Maximum Maintenance Dose of Epidyolex® | Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5) | |
| Secondary | Type, Dosage, and Frequency of Concomitant Anti-Seizure Medications (ASMs) | Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5) | |
| Secondary | Number of Participants Reducing Number/Dosage of Concomitant Medication Related to Epilepsy | Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5) | |
| Secondary | Change from Baseline to Week 28 (V3) in the Child Behavior Check List (CBCL) | Baseline to week 28 (V3) post-dose. | The CBCL is a standardized form that parents fill out to describe their children's behavioral and emotional problems(e.g., anxiety, depression, social problems). The CBCL is also scored on (optional) competence scales for activities, social relations, school and total competence. The CBCL consists of 113 questions, scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). A higher score indicates a worse outcome. |
| Secondary | Change from Baseline to Week 52 (V5) in the Child Behavior Check List (CBCL) | Baseline to week 52 (V5) post-dose. | The CBCL is a standardized form that parents fill out to describe their children's behavioral and emotional problems(e.g., anxiety, depression, social problems). The CBCL is also scored on (optional) competence scales for activities, social relations, school and total competence. The CBCL consists of 113 questions, scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). A higher score indicates a worse outcome. |
| Secondary | Change from Baseline to Week 28 (V3) in the Visual Analog Scale (VAS) of 10 Non-seizure Related Outcomes (NSRO) | Baseline to week 28 (V3) post-dose. | VAS assessments are based on 10 NSRO (i.e., Alertness, Sleep Disorder, Motor Skills, Attention, Cognition, Communication, Behavior, Emotional/Social Functioning, Activities of Daily Living, and Participation). VAS is measured on a scale of 0-100; a score of 0 indicates a better outcome, and a score of 100 indicates a worse outcome. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05485831
GET https://conductscience.org/api/trials/v1/NCT05485831/registered