Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders

NCT ID: NCT02324673

Last Updated: 2017-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-13
• Study Completion Date: 2016-05-09

Brief Summary

This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion.

Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant seizures, and satisfy all inclusion/exclusion criteria.

Conditions

Seizures

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Dose Cannabidiol Oral Solution [10 mg/kg/day]

Low Dose \[10 milligrams/kilogram/day (mg/kg/day)\] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.

Group Type: EXPERIMENTAL

Cannabidiol Oral Solution

Intervention Type: DRUG

An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).

Mid Dose Cannabidiol Oral Solution [20 mg/kg/day]

Mid Dose \[20 mg/kg/day\] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.

Group Type: EXPERIMENTAL

Cannabidiol Oral Solution

Intervention Type: DRUG

An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).

High Dose Cannabidiol Oral Solution [40 mg/kg/day]

High Dose \[40 mg/kg/day\] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.

Group Type: EXPERIMENTAL

Cannabidiol Oral Solution

Intervention Type: DRUG

An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).

Interventions

Cannabidiol Oral Solution

An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Meets protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
• Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
• In the opinion of the Investigator, the participants and parent(s)/caregiver(s) are willing and able to comply with the study procedures and visit schedules, including venipuncture, inpatient stay at the study center, dosing at the study center twice a day as needed while an outpatient), and the Follow-up Visits (if applicable)

Exclusion Criteria

• Participant or parent(s)/caregiver(s) have daily commitments during the study duration that would interfere with attending all study visits
• History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
• Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

1. the safety or well-being of the participant or study staff

2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)

3. the analysis of results

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

INSYS Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neha Parikh

Role: STUDY_DIRECTOR

INSYS Therapeutics Inc

Locations

University of California San Francisco Medical Center

San Francisco, California, United States

Miami Children's Hospital

Miami, Florida, United States

Child Neurology Center - NW F

Pensacola, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Clinical Research Center of Nevada LLC

Las Vegas, Nevada, United States

Oregon Health Services University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Texas Scottish Rite Hospital for Children

Dallas, Texas, United States

Mary Bridge Children's Hospital

Tacoma, Washington, United States

Countries

United States

References

Wheless JW, Dlugos D, Miller I, Oh DA, Parikh N, Phillips S, Renfroe JB, Roberts CM, Saeed I, Sparagana SP, Yu J, Cilio MR; INS011-14-029 Study Investigators. Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy. CNS Drugs. 2019 Jun;33(6):593-604. doi: 10.1007/s40263-019-00624-4.

Reference Type: DERIVED

PMID: 31049885 (View on PubMed)

Other Identifiers

INS011-14-029

Identifier Type: -

Identifier Source: org_study_id