A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants Wi… (NCT03421496) | Clinical Trial Compass
TerminatedPhase 3
A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
Stopped: The study was terminated due to slow enrollment and failure to identify adequate patients that met entry criteria.
United States2 participantsStarted 2018-09-05
Plain-language 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 vigabatrin alone in the treatment of infants newly diagnosed with Infantile Spasms (IS).
Who can participate
Age range1 Month – 24 Months
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Percentage of Participants Considered Complete Responders