Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures

Inclusion Criteria:

1. 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.

2. Male or female between 3 and 12 years (inclusive) at the time of onset and between 3
and 17 years of age (inclusive) at the time of consent.

3. Body weight ≥ 10 kg.

4. Diagnosed with childhood absence epilepsy (CAE), confirmed by electroencephalogram
(EEG), with ≥ 5 absence seizures during the 4-hour EEG with treatment-resistant
absence seizures, and has had an adequate trial of at least 2 anti-epileptic drugs
(AED)s and are treatment-resistant to at least one AED.

5. Willingness to not start a ketogenic diet during the Baseline or Treatment Period.

6. Have on average ≥ 5 absence seizures per day.

7. 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.

8. A sexually active male 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.

9. In the opinion of the investigator, the parent(s)/caregiver(s) is willing and able to
comply with the study procedures and visit schedules and the Follow-up Visits.

10. General good health based on physical and neurological examinations, medical history,
and clinical laboratory values completed during the Screening Visit that would
prohibit the patient from safely participating in the trial as judged by the
investigator.

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. Has a history of nonfebrile seizures other than absence seizures.

3. Has a history of febrile seizures after 3 years of age.

4. Has a history consistent with juvenile absence epilepsy or juvenile myoclonic
epilepsy.

5. Currently taking felbamate.

6. Currently taking phenytoin, fluvoxamine, carbamazepine, or St. John's Wort.

7. Currently taking concomitant medications that are strong inhibitors/inducers/sensitive
substrates with a narrow therapeutic index for cytochrome P450 3A4 (CYP3A4), CYP2C9,
or CYP2C19. (Stable doses of Valproic Acid during the screening, titration, treatment,
and follow-up periods are permitted).

8. Currently on a ketogenic diet.

9. In the opinion of the investigator, any clinically significant, unstable medical
abnormality, chronic disease, or a history of a clinically significant abnormality of
the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems.

10. Clinically significant abnormal liver function test (LFT) values, including albumin,
direct bilirubin, total bilirubin, aspartate aminotransferase (AST), and alanine
aminotransferase (ALT) ≥3 times the upper limit of normal (ULN).

11. History or presence of abnormal electrocardiograms (ECGs) that are clinically
significant in the opinion of the investigator.

12. Has a current or history of clinically significant intellectual disability or major
psychiatric disease, including autism spectrum disorder, which would interfere with
compliance.

13. For patients aged 7 to 17 years of age and for whom the Columbia Suicide Severity
Rating Scale (C-SSRS) is developmentally appropriate, an affirmative answer to queries
regarding active suicidal ideation with some intent to act but without a specific plan
or active suicidal ideation with a specific plan and intent on the C-SSRS assessment
at the Screening Visit.

14. Any history of attempted suicide.

15. Previously received any investigational drug or device or investigational therapy
within 30 days before Screening.

16. Taken any cannabinoids in the 30 days prior to the Screening Visit.

17. History of an allergic reaction or a known or suspected sensitivity to any substance
that is contained in the investigational product formulation.

18. Known infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

19. In the opinion of the investigator, the patient is unsuitable in any other way to
participate in this study.

20. Body weight < 10 kg or > 80 kg.

21. Patients who do not have at least 5 absence seizures on 4-hour video-EEG will be
considered screen failures.