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

• Status: Terminated
• Trial end date: 2019-06-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benuvia Therapeutics Inc.; INSYS Therapeutics Inc
• Treatments: Cannabidiol; Pharmaceutical Solutions

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.