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

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Brief Title

Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (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 pilot phase only will be described in this record. 2
      cohorts of 5 participants will be enrolled sequentially. All participants will receive
      GWP42003-P.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Number of Participants Free of Clinical Spasms

Condition

Infantile Spasms

Intervention

GWP42003-P

Study Arms / Comparison Groups

 GWP42003-P
Description:  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.

Publications

* 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

Drug

Estimated Enrollment

9

Start Date

April 24, 2017

Completion Date

May 7, 2018

Primary Completion Date

May 7, 2018

Eligibility Criteria

        Key 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.

        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.
      

Gender

All

Ages

1 Month - 24 Months

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT02953548

Organization ID

GWEP15100 Pilot Phase

Secondary IDs

2015-004904-50

Responsible Party

Sponsor

Study Sponsor

GW Research Ltd


Study Sponsor

, , 


Verification Date

July 2020