Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
Condition: Childhood Absence Epilepsy
MeSH terms: Seizures; Epilepsy, Absence
Intervention: Cannabidiol Oral Solution
Intervention description: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.