Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GW Research Ltd

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The pilot phase only will be described in this record. 2 cohorts of 5 participants will be enrolled sequentially. All participants will receive GWP42003-P.

Research Team

Eligibility Criteria

Inclusion Criteria

Participant is aged 6- 24 months (inclusive) in the first cohort or aged 1-24 months (inclusive) in the second cohort, at the time of consent.

Participant is diagnosed with IS and has failed to respond adequately following treatment with 1 or more approved IS therapies.

To be considered hypsarrhythmia, as defined for use in the study, the electroencephalography (EEG) background must be slowed and have multifocal spikes. In addition, it must be either high voltage (above 300 µV) or have electrodecrement/discontinuity.

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Treatment Details

Interventions

GWP42003-P (Cannabinoid)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: GWP42003-PExperimental Treatment1 Intervention

Administered orally, titrating to a target dose of 40 mg/kg/day. Participants continue at the target dose, or the highest tolerated dose up to the target dose, for the remainder of the 2-week treatment period.

GWP42003-P is already approved in Canada for the following indications:

Approved in Canada as Sativex for:

Symptomatic relief of spasticity in adult patients with multiple sclerosis
Adjunctive analgesic treatment for moderate to severe pain in adult patients with advanced cancer