Status:
TERMINATED
A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
Lead Sponsor:
Radius Pharmaceuticals, Inc.
Conditions:
Infantile Spasm
Eligibility:
All Genders
1-24 years
Phase:
PHASE3
Brief Summary
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 vigaba...
Detailed Description
This was a randomized, double-blind, placebo-controlled, parallel-group study in which participants were randomized in a 1:1 ratio to 1 of 2 treatment groups. During the Initial Treatment Period, part...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03421496
Start Date
September 5 2018
End Date
May 29 2019
Last Update
June 7 2023
Active Locations (5)
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1
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
2
Beaumont Children's Hospital
Royal Oak, Michigan, United States, 48073
3
Akron Children's Hospital
Akron, Ohio, United States, 44308
4
Oregon Health & Science University
Portland, Oregon, United States, 97239