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

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ClinicalTrials.gov Identifier: NCT03355300
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

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.

Condition or disease Intervention/treatment Phase
Childhood Absence Epilepsy Drug: Cannabidiol Oral Solution Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Experimental: Cannabidiol Oral Solution
Cannabidiol Oral solution, dose as assigned in INS-17-103.
Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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 patient 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.

  2. Number of Participants with Change from Baseline in Vital Signs at Visit 8 [ Time Frame: Baseline (Visit 6 of INS011-17-103) and Visit 8 (approximately Week 48) ]
  3. Number of Participants with Change from Baseline in Physical Exam at Visit 8 [ Time Frame: Baseline (Visit 6 of INS011-17-103) and Visit 8 (approximately Week 48) ]
    The physical examination will consist of an evaluation of general appearance, skin, eyes, ears, nose, throat, neck, lymph nodes, chest, heart, abdomen, and extremities.

  4. Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings at Visit 8 [ Time Frame: Baseline (Visit 6 of INS011-17-103) and Visit 8 (approximately Week 48) ]
  5. Number of Participants with Change from Baseline in Laboratory Values at Visit 8 [ Time Frame: Baseline (Visit 6 of INS011-17-103) and Visit 8 (approximately Week 48) ]
  6. Number of Participants with Change from Baseline in Neurological Examination at Visit 8 [ Time Frame: Baseline (Visit 6 of INS011-17-103) and Visit 8 (approximately Week 48) ]
    The neurological examination will consist of an evaluation of mental status, cranial nerves, nystagmus, motor system, sensory system, reflexes, coordination, gait, and station.



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355300


Locations
United States, Florida
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Research Coordinator    786-624-3516    tami.quintero@mch.com   
Pediatric Epilepsy and Neurology Specialists Recruiting
Tampa, Florida, United States, 33609
Contact: Research Coordinator    813-873-7367    mayra@pensresearch.org   
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Research Coordinator    330-543-0690    jkatz@akronchildrens.org   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Research Coordinator    503-494-8881    straussc@ohsu.edu   
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Research Coordinator    215-590-4136    minnick@email.chop.edu   
United States, Virginia
Children's Specialty Group, Division of Child & Adolescent Neurology Recruiting
Norfolk, Virginia, United States, 23510
Contact: Research Coordinator    757-668-9356    Terrie.Conklin@chkd.org   
United States, Washington
Institute for Research and Innovation | MultiCare Health System Recruiting
Tacoma, Washington, United States, 98405
Contact: Research Coordinator    253-403-9348    ccanorro@multicare.org   
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
Study Director: Giovanni DeCastro INSYS Therapeutics Inc

Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT03355300     History of Changes
Other Study ID Numbers: INS011-17-113
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Seizures
Epilepsy, Absence
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Epilepsy, Generalized
Pharmaceutical Solutions