Trial · NCT06924827
A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
NCT06924827, Phase 4, Not yet recruiting, Elizabeth Donner
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex. Trials, record NCT06924827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06924827
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
- NCT number
- NCT06924827
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 25 participants, estimated
- Lead sponsor
- Elizabeth Donner
- Conditions
- Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
- Interventions
- Epidiolex 100 mg/mL Oral Solution
- First posted
- 2025-04-11
- Last updated
- 2026-09-11
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The success rate of transition of children from 'artisanal' CBD to Epidiolex. | Baseline (visit 2, Day 1) through visit 4 (Day 15), the two-week transition phase. | Participants successfully transitioned from 'artisanal' CBD to Epidiolex if they complete the transition protocol and continue treatment with Epidiolex at visit 2 following the two-week transition phase of the study. The success rate will be determined as the percentage of participants that complete the two-week transition phase. |
| Secondary | The acceptability rate of Epidiolex in children previously treated with 'artisanal' CBD. | Baseline (visit 2, Day 15) to end of treatment (visit 7, Day 85). | Participants accepted transition to Epidiolex if they continued treatment with Epidiolex after the last scheduled visit of the maintenance period (visit 7). The acceptability rate will be determined as the percentage of participants that continue treatment with Epidiolex after the last scheduled visit of the maintenance period (visit 7, Day 85). |
| Secondary | The change in seizure frequency following transition of children from 'artisanal' CBD to Epidiolex. | Baseline (visit 2, Day 1) through the end of treatment (visit 7, Day 85). | The percent change (increase or decrease) from baseline in 28-day seizure frequency during the maintenance period. Seizure frequency will be calculated as the total number of seizures divided by the number of days with seizure data, multiplied by 28. |
| Secondary | Change in reported Pediatric Epilepsy Side-Effects Questionnaire (PESQ) score. | Baseline (visit 2, Day 1) through visit 4 (Day 15), visit 5 (Day 29) and end of treatment (visit 7, Day 85). | The Pediatric Epilepsy Side Effects Questionnaire (PESQ) is a rating scale to assess pediatric participant-reported side effects associated with anti-seizure medication treatment. Each side-effect is rated on a 6-point Likert scale as follows: (1) - "Not present", (2) - "Low severity", (3) - "Low-moderate severity", (4) - "Moderate severity", (5) - "Moderate-high severity", (6) - "High severity". Higher scores indicated worse side-effects. |
| Secondary | Change Clinical Global Impression of Improvement (CGI-I) score. | Baseline (visit 2, Day 1) through visit 5 (Day 29) and end of treatment (visit 7, Day 85). | The Clinical Global Impression of Improvement (CGI-I) is a 7-point Likert scale used to rate the overall change in seizure control, behaviour, safety and tolerability after transitioning to Epidiolex relative to baseline. The participant's overall improvement is rated by the clinician and caregiver as: 1- "very much improved", 2- "much improved', 3- "minimally improved", 4- "no change", 5- "minimally worse", 6- "much worse", and 7- "very much worse". Higher scores indicate worse condition. |
| Secondary | Change in Clinical Global Impression of Seizure Intensity/Duration (CGI-CSID) score. | Baseline (visit 2, Day 1) through visit 5 (Day 29) and end of treatment (visit 7, Day 85). | The Clinical Global Impression of Change in Seizure Intensity/Duration (CGI-CSID) is a 7-point Likert scale used to rate the overall change in seizure intensity and/or duration after transitioning to Epidiolex relative to baseline. The participant's overall improvement is rated by the clinician and caregiver as: 1- "very much improved", 2- "much improved', 3- "minimally improved", 4- "no change", 5- "minimally worse", 6- "much worse", and 7- "very much worse". Higher scores indicate worse condition. |
| Secondary | Change in Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) score. | Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85). | The Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) is a caregiver-reported questionnaire that evaluates quality of life in epileptic children. It contains 55 questions that measure quality of life in 4 areas: cognitive functioning, emotional functioning, social functioning, and physical functioning. Each question is rated on a 5-point Likert scale, with the option to answer "not applicable" as follows: (1) - "All of the time", (2) - "Most of the time", (3) - "Some of the time", (4) - "A little of the time", (5) - "None of the time", (6) - Not applicable. Higher scores indicate higher health-related quality of life. |
| Secondary | Change in Measure Yourself Medical Outcome Profile 2 (MYMOP2) score. | Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85) | The Measure Yourself Medical Outcome Profile 2 (MYMOP2) questionnaire is a scale that allows participants or caregivers to identify the problem(s) that are most important to them/the participant, and rate the severity of the problem (s) on a 7-point Likert scale ranging from 0 (as good as it can be) to 6 (as bad as it could be). Higher scores indicate worse problems. |
| Secondary | Change in Children's Sleep Habit Questionnaire (CSHQ) score. | Baseline (visit 2, Day 1) through visit 5 (Day 29) and end of treatment (visit 7, Day 85). | The Children's Sleep Habit Questionnaire (CSHQ) is a caregiver-reported questionnaire to measure sleep behaviours in children. The questionnaire has 45 questions about bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. Each question is rated on a 3-point Likert scale as follows: (1) - "Usually (5 or more times in a week)", (2) - "Sometimes (2-4 times in a week)", (3) - Rarely (never or 1 time during a week). A higher score indicates more sleep problems. |
| Secondary | Number of dose increases in anti-seizure medications (ASMs) after starting Epidiolex. | Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85). | The number of dose increases in anti-seizure medications (ASMs), including Epidiolex, due to worsening seizure burden or other factors. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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/NCT06924827
GET https://conductscience.org/api/trials/v1/NCT06924827/registered