Trial · NCT03355300
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
NCT03355300, Phase 2, Terminated, Radius Pharmaceuticals, Inc.; results first posted 2023-06-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures. Trials, record NCT03355300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03355300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
- NCT number
- NCT03355300
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Radius Pharmaceuticals, Inc.
- Conditions
- Childhood Absence Epilepsy
- Interventions
- Cannabidiol Oral Solution
- First posted
- 2017-11-28
- Last updated
- 2023-06-18
- Results first posted
- 2023-06-18
- Limitations and caveats
- This study was prematurely terminated by the Sponsor. Participants ongoing at the time of discontinuation of the study are neither considered completed or discontinued.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline (Visit 6 of INS011-17-103) and Visit 10 (up to approximately 54 weeks) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported AEs module. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline (Visit 6 of INS011-17-103) and Visit 10 (up to approximately 54 weeks) | All participants who were enrolled and received at least 1 dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Canabidiol Oral Solution 20 to <30 mg/kg/Day | Number of participants with AEs | 5 | participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Canabidiol Oral Solution 30 to <40 mg/kg/Day | Number of participants with AEs | 4 | participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Canabidiol Oral Solution 20 to <30 mg/kg/Day | Number of participants with SAEs | 0 | participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Canabidiol Oral Solution 30 to <40 mg/kg/Day | Number of participants with SAEs | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 5 | |
| Overall Study | STARTED | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 6 | |
| Overall Study | COMPLETED | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 2 | |
| Overall Study | COMPLETED | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 4 | |
| Overall Study | NOT COMPLETED | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 3 | |
| Overall Study | NOT COMPLETED | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 2 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 0 | 5 | |
| other | Vomiting | Gastrointestinal disorders | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 1 | 6 | |
| other | Fatigue | General disorders | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 0 | 5 | |
| other | Fatigue | General disorders | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 1 | 6 | |
| other | Pyrexia | General disorders | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 1 | 5 | |
| other | Pyrexia | General disorders | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 0 | 6 | |
| other | Seasonal allergy | Immune system disorders | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 1 | 5 | |
| other | Seasonal allergy | Immune system disorders | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 0 | 6 | |
| other | Pharyngitis streptococcal | Infections and infestations | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 0 | 5 | |
| other | Pharyngitis streptococcal | Infections and infestations | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 1 | 6 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 0 | 5 |
| Total, all-cause mortality | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 0 | 6 |
| Total, other adverse events | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 4 | 5 |
| Total, other adverse events | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 4 | 6 |
| Total, serious adverse events | Canabidiol Oral Solution 20 to <30 mg/kg/Day | 0 | 5 |
| Total, serious adverse events | Canabidiol Oral Solution 30 to <40 mg/kg/Day | 0 | 6 |
Source ClinicalTrials.gov
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Canabidiol Oral Solution 20 to <30 mg/kg/Day vs Canabidiol Oral Solution 30 to <40 mg/kg/Day: deaths from any cause | Trial comparisons |
| Canabidiol Oral Solution 20 to <30 mg/kg/Day vs Canabidiol Oral Solution 30 to <40 mg/kg/Day: serious adverse events | Trial comparisons |
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/NCT03355300
GET https://conductscience.org/api/trials/v1/NCT03355300/events?page=2