Tricaprilin Infantile Spasms Pilot Study

Prior treatment

• Subject considered by the Investigator, for any reason, to be an unsuitable candidate to receive the investigational product
• Known or suspected allergy to the investigational product
• Previous participation in another clinical study of the investigational product or received any investigational drug, device, or therapy within 30 days of study entry or within five half-lives of another investigational drug
• Within 14 days of screening, subject has:
  • received therapy with felbamate, cannabinoids, ketogenic diet, or vagus nerve stimulation
  • received therapy with ACTH, prednisolone or other steroid
• Previous failure to respond to an appropriate trial (at least 2 weeks) of the ketogenic diet

Other illness

• Significant and active pre-existing cardiovascular, renal, liver, infectious, or other systemic disease
• Subject has clinically significant renal impairment
• Known history of aspiration pneumonia within the past year
• Pre-existing lethal or potentially lethal condition other than infantile spasms

Other

• Clinically significant abnormality on ECG that, in the opinion of the Investigator, increases the safety risks of participating in the study

• Male and female infants ages 3 months to 24 months, inclusive, at the time of parent/legal guardian signing the informed consent
• Clinical diagnosis of IS, confirmed by analysis of a 24-hour video-electroencephalogram (vEEG) recording, including at least one documented spasm
• Continued infantile spasms despite adequate treatment with oral prednisolone (or adrenocorticotropic hormone \[ACTH\]) and vigabatrin
• If being treated with concomitant ASDs (other than ketogenic therapies/diet), current ASDs have been at a constant daily dose for at least 1 week.
• Subject is taking no more than 3 concomitant ASDs