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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 : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

November 9, 2017
November 28, 2017
July 3, 2018
February 20, 2018
November 2019   (Final data collection date for primary outcome measure)
  • 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.
  • 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) ]
  • 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.
  • 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) ]
  • 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) ]
  • 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.
Same as current
Complete list of historical versions of study NCT03355300 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Childhood Absence Epilepsy
Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Experimental: Cannabidiol Oral Solution
Cannabidiol Oral solution, dose as assigned in INS-17-103.
Intervention: Drug: Cannabidiol Oral Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
November 2019
November 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
3 Years to 17 Years   (Child)
No
United States
 
 
NCT03355300
INS011-17-113
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
INSYS Therapeutics Inc
INSYS Therapeutics Inc
Not Provided
Study Director: Giovanni DeCastro INSYS Therapeutics Inc
INSYS Therapeutics Inc
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP