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

Primary Purpose

Childhood Absence Epilepsy

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol Oral Solution
Sponsored by
Radius Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Absence Epilepsy

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Completed all activities through Visit 6 (End of Study) of INS011-17-103.
  2. Patient 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 patient 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 patient or partner of enrolled patient 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. Patient 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 patient.
  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 patient is unsuitable in any other way to participate in this study.

Sites / Locations

  • Nicklaus Children's Hospital
  • Pediatric Epilepsy and Neurology Specialists
  • Clinical Integrative Research Center of Atlanta
  • Akron Children's Hospital
  • Oregon Health and Science University
  • Children's Hospital of Philadelphia
  • Primary Children's Hospital
  • Children's Specialty Group, Division of Child & Adolescent Neurology
  • Institute for Research and Innovation | MultiCare Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cannabidiol Oral Solution

Arm Description

Cannabidiol Oral solution, dose as assigned in INS-17-103.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2017
Last Updated
May 24, 2023
Sponsor
Radius Pharmaceuticals, Inc.
Collaborators
Benuvia Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03355300
Brief Title
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Insys Therapeutics filed Chapter 11 and terminated all studies.
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
June 24, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radius Pharmaceuticals, Inc.
Collaborators
Benuvia Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Absence Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol Oral Solution
Arm Type
Experimental
Arm Description
Cannabidiol Oral solution, dose as assigned in INS-17-103.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol Oral Solution
Intervention Description
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline (Visit 6 of INS011-17-103) and Visit 10 (up to approximately 54 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed all activities through Visit 6 (End of Study) of INS011-17-103. 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. 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. 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. 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: Participant or parent(s)/caregiver(s) have daily commitments during the study duration that would interfere with attending all study visits. Experienced an anoxic episode related to study drug requiring resuscitation during their previous study. 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. Evidence of other clinically significant disease such as unstable hepatic, hematological, renal, cardiovascular, gastrointestinal, immunological, or pulmonary diseases or ongoing malignancies. Compromised respiratory function or severe respiratory insufficiency. Clinically significant abnormal laboratory values within the past 14 days. In the opinion of the investigator, the participant is unsuitable in any other way to participate in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Elkashef, MD
Organizational Affiliation
INSYS Therapeutics Inc
Official's Role
Study Director
Facility Information:
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Pediatric Epilepsy and Neurology Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Clinical Integrative Research Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Children's Specialty Group, Division of Child & Adolescent Neurology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Institute for Research and Innovation | MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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