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

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Brief Title

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

Official Title

A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study

Brief Summary

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

Study Phase

Phase 3

Study Type


Primary Outcome

Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)

Secondary Outcome

 Number of Participants Free of Clinical Spasms


Infantile Spasms



Study Arms / Comparison Groups

Description:  Administered orally, up to the target dose recommended by the data safety monitoring committee.
Participants continue at the target dose, or the highest tolerated dose up to the target dose, for a total of 12 months' treatment.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

May 12, 2017

Completion Date

June 13, 2019

Primary Completion Date

June 13, 2019

Eligibility Criteria

        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.




1 Month - 24 Months

Accepts Healthy Volunteers



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Location Countries


Location Countries


Administrative Informations



Organization ID

GWEP15100 Open-label Extension

Secondary IDs


Responsible Party


Study Sponsor

Jazz Pharmaceuticals

Study Sponsor

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Verification Date

August 2022