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

Childhood Absence Epilepsy Clinical Trial

Official title:

A Multicenter, Open-Label, Flexible Dose Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Patients With Treatment-Resistant Childhood Absence Seizures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03355300
• Other study ID #: INS011-17-113
• Status: Terminated
• Phase: Phase 2
• Start date: February 20, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: May 2023
• Source: Radius Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 28, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Completed all activities through Visit 6 (End of Study) of INS011-17-103.

2. Participant and/or parent(s)/caregiver(s) fully comprehend the informed consent form (ICF) and assent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.

3. A female participant is eligible to participate in the study if she is premenarchal, or of childbearing potential with a negative urine pregnancy test at the Screening Visit. If sexually active, she must agree to either complete abstinence from intercourse or use acceptable methods of contraception throughout the study and for 4 weeks after completion of study participation or discontinuation from investigational product.

4. A sexually active male participant or partner of enrolled participant must be willing to use acceptable methods of contraception throughout the study and for 4 weeks after completion of study participation or discontinuation from investigational product.

5. In the opinion of the investigator, the parent(s)/caregiver(s) is (are) willing and able to comply with the study procedures and visit schedules, including venipuncture, and the visit schedules.

Exclusion Criteria:

1. Participant or parent(s)/caregiver(s) have daily commitments during the study duration that would interfere with attending all study visits.

2. Experienced an anoxic episode related to study drug requiring resuscitation during their previous study.

3. Developed an adverse event thought to be related to CBD in the previous study and for whom the Investigator determines that continuing treatment with CBD would not be in the best interest of the participant.

4. Evidence of other clinically significant disease such as unstable hepatic, hematological, renal, cardiovascular, gastrointestinal, immunological, or pulmonary diseases or ongoing malignancies.

5. Compromised respiratory function or severe respiratory insufficiency.

6. Clinically significant abnormal laboratory values within the past 14 days.

7. In the opinion of the investigator, the participant is unsuitable in any other way to participate in this study.

Related Conditions & MeSH terms

• Childhood Absence Epilepsy
• Epilepsy, Absence
• Seizures

Intervention

Drug:
• Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio
United States	Clinical Integrative Research Center of Atlanta	Atlanta	Georgia
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Children's Specialty Group, Division of Child & Adolescent Neurology	Norfolk	Virginia
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Institute for Research and Innovation | MultiCare Health System	Tacoma	Washington
United States	Pediatric Epilepsy and Neurology Specialists	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Radius Pharmaceuticals, Inc.	Benuvia Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Baseline (Visit 6 of INS011-17-103) and Visit 10 (up to approximately 54 weeks)