Trial · NCT06738732
CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And/or Lennox-Gastaut Syndrome
NCT06738732, Phase 1, Phase 2, Not yet recruiting, Alexander Rotenberg
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And/or Lennox-Gastaut Syndrome. Trials, record NCT06738732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06738732
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And/or Lennox-Gastaut Syndrome
- NCT number
- NCT06738732
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 25 participants, estimated
- Lead sponsor
- Alexander Rotenberg
- Conditions
- Lennox-Gastaut Syndrome (LGS), Dravet Syndrome (DS)
- Interventions
- CBD: GT4 Transdermal Delivery System
- First posted
- 2024-12-18
- Last updated
- 2024-12-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compliance | 112 Days | Proportion of participants compliant with study dosing regimen for visits at baseline, 7, 14, 21, 28, 56, 84, and 112 days post treatment; |
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 112 Days | Pre-emergent and post-emergent adverse events will be described in separate frequency tables. The description, frequency, type, severity, causality, and outcome of each adverse event will also be listed. |
| Secondary | Seizure Frequency | 112 Days | Proportion, relative to baseline will be computed for three seizure types: (1) drop, (2) generalized tonic, and (3) generalized tonic-clonic. Seizure freqeuncy values will be collected 28, 56, 84 and 112 days post treatment to compute percent change in frequency at 28, 56, 84 and 112 days post treatment. |
| Secondary | CBD, 7-COOH-CBD, and 7-OH-CBD blood concentrations, and blood concentrations of concomitant AEDs | 112 Days | Blood will be collected at morning trough, before morning medicaiton adminitration. Summary statistics including means, standard deviations, medians, minimums, maximums, on secondary outcome variables: CBD, 7-COOH-CBD, and 7-OH-CBD blood concentrations, and blood concentrations of concomitant AEDs will be obtained for baseline, 1, 7, 14, 21, 28, 56, 84 and 112 days post treatment for the overall ITT and PP populations. Similar summary statistics will also be obtained for changes from baseline to 1, 7, 14, 21, 28, 56, 84 and 112 days post treatment. |
Source ClinicalTrials.gov
Outcomes0
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/NCT06738732
GET https://conductscience.org/api/trials/v1/NCT06738732/registered