Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)

Only participants who completed the pilot or pivotal phases of the trial may proceed to take part in this open-label extension phase of the trial. Key eligibility criteria for the blinded phase were as follows: Key Inclusion Criteria: * Participant is diagnosed with IS and has failed to respond adequately following treatment with 1 or more approved IS therapies. Key Exclusion Criteria: * Participant is currently taking or has taken clobazam or any mammalian target of rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit. * Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB), of 460 msec or greater on ECG. * Participant's caregiver is currently giving or has given recreational or medicinal cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the screening visit. * Participant's caregiver is unwilling to abstain from giving the participant (including the participant's mother abstaining themselves, if breastfeeding)recreational or medicinal cannabis, or synthetic cannabinoid-based medications (other than the study drug) during the trial. * Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study drug, such as sesame oil. * Participant has significantly impaired hepatic function at the screening visit. * Participant has received an investigational medicinal product as part of a clinical trial within a minimum of 5 half-lives prior to the scr…