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Terminated Phase 2 Interventional Results available

Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms

ClinicalTrials.gov ID: NCT02551731

Public ClinicalTrials.gov record NCT02551731. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 10:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2 Study to Assess the Efficacy and Safety of Cannabidiol Oral Solution for the Treatment of Refractory Infantile Spasms

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS. This need is even more important for infants and toddlers still sick after being treated with medicine that is already available. This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution (CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of infantile spasms who have not responded to first line therapies. The overall study duration is expected to be 64 weeks for those subjects who respond to CBD treatment. The maximum possible study duration for each patient is approximately 64 weeks, however a subject will be deemed to have completed the study after 58 weeks.

Study identification

NCT ID
NCT02551731
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
INSYS Therapeutics Inc
Industry
Enrollment
9 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Months to 36 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 26, 2016
Primary completion
Sep 5, 2016
Completion
Sep 5, 2016
Last update posted
Sep 18, 2018

2016

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
4
Facility City State ZIP Site status
Mattel Children's Hospital at UCLA Los Angeles California 90095
University of California - San Francisco San Francisco California 94143
Miami Children's Hospital Miami Florida 33155
Beaumont Health System Royal Oak Michigan 48073

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02551731, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 18, 2018 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02551731 live on ClinicalTrials.gov.

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