A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Infantile Spasm

In brief

The primary purpose of this study was to evaluate the efficacy, safety, and tolerability of Cannabidiol Oral Solution (CBD) as adjunctive therapy with vigabatrin as initial therapy, compared to vigabatrin alone in the treatment of infants newly diagnosed with Infantile Spasms (IS).

Key facts

Study ID

NCT03421496

Run by

Radius Pharmaceuticals, Inc.

People needed

2

Starts

2018-09-05

Expected to finish

2019-05-29

Last updated by the study team

2023-06-07

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parent(s)/caregiver(s) fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.
• Clinical diagnosis of Infantile Spasms, confirmed by video-EEG (including at least one cluster of electroclinical spasms [≥3 in any 10-minute epoch] and hypsarrythmia) obtained during the Screening Period and read by a central reader.
• General good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on physical and neurological examinations, medical history, and clinical laboratory values completed during the Screening Visit).
• 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.

You may not qualify if…

• Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator's Brochure for Cannabidiol Oral Solution) to be an unsuitable candidate to receive the study drug.
• Known or suspected allergy to cannabidiol.
• History of an allergic reaction or a known or suspected sensitivity to any substance that is contained in the investigational product formulation.
• Use of any cannabidiol/cannabis product within 30 days of study entry.
• Participant is diagnosed or suspected of having tuberous sclerosis.
• Participant has received treatment with either vigabatrin, ACTH, or high-dose steroids previously.
• Previous or concomitant therapy with felbamate, clobazam, valproic acid, or the ketogenic diet.
• Participant currently on any disallowed CYP3A4-related medication (phenytoin, fluvoxamine, carbamazepine, and St. John's Wort).
• Previously received any investigational drug or device or investigational therapy within 30 days before Screening.
• Clinically significant abnormal laboratory values, including: liver function tests (LFTs) such as albumin, direct bilirubin, total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN). The investigator may deem the participant eligible if he or she judges the laboratory values to be not clinically significant.

Where it is running

• Nicklaus Children's Hospital — Miami, Florida, United States
• Beaumont Children's Hospital — Royal Oak, Michigan, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Institute for Research and Innovation | MultiCare Health System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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