Trial · NCT03467113
A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
NCT03467113, Phase 1, Completed, Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol. Trials, record NCT03467113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03467113
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
- NCT number
- NCT03467113
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Conditions
- Dravet Syndrome, Lennox Gastaut Syndrome
- Interventions
- ZX008 0.2 to 0.8 mg/kg/day, Cannabidiol
- First posted
- 2018-03-15
- Last updated
- 2023-12-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | Baseline to Day 365 | Number of adverse events including serious adverse events, number of adverse events leading to study withdrawal |
| Primary | Change in Heart Rate | Baseline to Day 365 | Change in resting heart rate using standard measures |
| Primary | Change in blood pressure | Baseline to Day 365 | Change in resting blood pressure using standard measures |
| Primary | Change in temperature | Baseline to Day 365 | Change in resting temperature using standard measures |
| Primary | Change in respiratory rate | Baseline to Day 365 | Change in resting respiratory rate using standard measures |
| Primary | Changes in heart rhythm | Baseline to Day 365 | Changes in heart beat as measured with 12-lead electrocardiogram |
| Primary | Changes in heart valve function | Baseline to Day 365 | Changes in heart valves as measured with standard echocardiogram |
| Primary | Changes in treatment-emergent body weight and height | Baseline to Day 365 | Changes in body weight and height by report of BMI in kg/m\^2 |
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/NCT03467113
GET https://conductscience.org/api/trials/v1/NCT03467113/registered