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Keep this study
Lead
INSYS Therapeutics Inc
A protocol amendment in May 2016 created two parts to this trial: Part A (the extended treatment period) and Part B (the safety treatment period), whose objectives are as follows:
Primary Part A: To evaluate the efficacy of Cannabidiol Oral Solution in treating refractory infantile spasms (IS).
Secondary:
Part A:
* To evaluate the safety of Cannabidiol Oral Solution in treating refractory infantile spasms.
Part B:
* To assess the long-term safety of Cannabidiol Oral Solution as an adjunctive treatment for subjects with Infantile Spasms (IS)
* To establish the continued efficacy of Cannabidiol Oral Solution in maintaining seizure control in subjects with IS
* To assess the global status of subjects taking Cannabidiol Oral Solution for an extended period of time determined by various qualitative assessments
* To monitor for changes in plasma levels of Cannabidiol Oral Solution during long-term treatment of subjects with IS
Age
0–3
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Meets protocol-specified criteria for qualification, including infantile spasms
Parent(s)/caregiver(s) fully comprehend and sign the informed consent form, understand all study procedures, and can communicate satisfactorily with the Investigator and study coordinator.
You may not be if
History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
1. the safety or well-being of the participant or study staff
2. the analysis of results
During the Safety Treatment and Follow-up Periods, subjects are not to receive the following:
1. any cannabinoids (CBD, Δ9-tetrahydrocannabinol (THC), hemp oil, Realm Oil or marijuana)
2. any other investigational drug or investigational device
