NCT03355300

Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures

Terminated Phase 2 Results posted Last updated 18 June 2023

What this trial tests

Phase 2 trial testing Cannabidiol Oral Solution in Childhood Absence Epilepsy in 11 participants. Terminated before completion.

Timeline

20 February 2018

Primary endpoint
24 June 2019

28 June 2019

Quick facts

Lead sponsor	Radius Pharmaceuticals, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	20 February 2018
Primary completion	24 June 2019
Estimated completion	28 June 2019
Sites	9 locations across United States

Drugs / interventions tested

• Cannabidiol Oral Solution — full drug profile →

Conditions studied

• Childhood Absence Epilepsy — all drugs for Childhood Absence Epilepsy →

Sponsor

Radius Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 3 to 17, any sex, with Childhood Absence Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · 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 hospitali

Number of participants with AEs

Group	Value	95% CI
Canabidiol Oral Solution 20 to <30 mg/kg/Day	5
Canabidiol Oral Solution 30 to <40 mg/kg/Day	4

Number of participants with SAEs

Group	Value	95% CI
Canabidiol Oral Solution 20 to <30 mg/kg/Day	0
Canabidiol Oral Solution 30 to <40 mg/kg/Day	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline (Visit 6 of INS011-17-103) and Visit 10 (up to approximately 54 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Canabidiol Oral Solution 20 to <30 mg/kg/Day

Serious: 0/5 (0%)

Deaths: 0/5

Canabidiol Oral Solution 30 to <40 mg/kg/Day

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (11 terms — click to expand)

Reaction	System	Canabidiol Oral Solution 2…	Canabidiol Oral Solution 3…
Vomiting	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Pyrexia	General disorders	—	—
Seasonal allergy	Immune system disorders	—	—
Pharyngitis streptococcal	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Coordination abnormal	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Seizure	Nervous system disorders	—	—
Somnolence	Nervous system disorders	—	—
Hallucination	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT03355300 adverse events section.

Sponsor's own description

The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical and experimental insight into pathophysiology, comorbidity and therapy of absence seizures.
   Crunelli V, Lőrincz ML, McCafferty C, Lambert RC, et al · · 2020 · cited 132× · PMID 32437558 · DOI 10.1093/brain/awaa072
2. Use of Cannabidiol in the Treatment of Epilepsy: Efficacy and Security in Clinical Trials.
   Silvestro S, Mammana S, Cavalli E, Bramanti P, et al · · 2019 · cited 114× · PMID 31013866 · DOI 10.3390/molecules24081459
3. Dysregulation of the Cannabinoid System in Childhood Epilepsy: From Mechanisms to Therapy.
   Montebello G, Di Giovanni G. · · 2025 · cited 2× · PMID 40650012 · DOI 10.3390/ijms26136234