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 screening visit.