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

Stopped early · Phase 2

Conditions studied: Childhood Absence Epilepsy

In brief

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.

Key facts

Study ID

NCT03355300

Run by

Radius Pharmaceuticals, Inc.

People needed

11

Starts

2018-02-20

Expected to finish

2019-06-28

Last updated by the study team

2023-06-18

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed all activities through Visit 6 (End of Study) of INS011-17-103.
• 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.
• 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.
• 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.
• 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.

You may not qualify if…

• Participant or parent(s)/caregiver(s) have daily commitments during the study duration that would interfere with attending all study visits.
• Experienced an anoxic episode related to study drug requiring resuscitation during their previous study.
• 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.
• Evidence of other clinically significant disease such as unstable hepatic, hematological, renal, cardiovascular, gastrointestinal, immunological, or pulmonary diseases or ongoing malignancies.
• Compromised respiratory function or severe respiratory insufficiency.
• Clinically significant abnormal laboratory values within the past 14 days.
• In the opinion of the investigator, the participant is unsuitable in any other way to participate in this study.

Where it is running

• Nicklaus Children's Hospital — Miami, Florida, United States
• Pediatric Epilepsy and Neurology Specialists — Tampa, Florida, United States
• Clinical Integrative Research Center of Atlanta — Atlanta, Georgia, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Children's Specialty Group, Division of Child & Adolescent Neurology — Norfolk, Virginia, United States
• Institute for Research and Innovation | MultiCare Health System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.