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

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ClinicalTrials.gov Identifier: NCT02954887
Recruitment Status : Active, not recruiting
First Posted : November 4, 2016
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE November 4, 2016
Last Update Posted Date July 16, 2018
Actual Study Start Date  ICMJE May 9, 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • Number of participants who experienced a treatment-emergent adverse event. [ Time Frame: 1 year ]
    The number of participants who experienced an adverse event that started, or worsened in severity or seriousness, following the first dose of study drug is presented.
  • Number of participants with a potentially clinically significant change in clinical laboratory tests. [ Time Frame: 1 year ]
    The number of participants with a potentially clinically significant change in clinical laboratory tests is presented.
  • Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG). [ Time Frame: 1 year ]
    The number of participants with a clinically significant change in ECG is presented.
  • Number of participants with a clinically significant change in vital signs. [ Time Frame: 1 year ]
    The number of participants with a clinically significant change in vital signs (systolic and diastolic blood pressure, pulse rate, body temperature and respiratory rate) is presented.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02954887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • Number of treatment responders. [ Time Frame: 1 year ]
    The number of participants who are free of spasms and have resolution of hypsarrhythmia is presented.
  • Number of participants who are spasm-free. [ Time Frame: 1 year ]
    The number of participants who are free of clinical spasms is presented.
  • Number of participants without hypsarrhythmia. [ Time Frame: 1 year ]
    The number of participants with resolution of hypsarrhythmia is presented.
  • Changes in seizures by subtype. [ Time Frame: 1 year ]
    Changes in seizures by subtype are presented.
  • Change in overall condition as assessed by the caregiver. [ Time Frame: 1 year ]
    The change in overall condition was assessed using the Caregiver Clinical Global Impression of Change (CGIC) questionnaire.
  • Change in overall condition as assessed by the investigator. [ Time Frame: 1 year ]
    The change in overall condition was assessed using the Investigator Clinical Global Impression of Change (IGIC) questionnaire.
  • Number of participants with relapse of spasms. [ Time Frame: 1 year ]
    The number of participants with relapse of spasms is presented.
  • Change in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) score. [ Time Frame: Baseline and 1 year ]
    Change from baseline in Vineland-II score is presented.
  • Change in length (height) and head circumference. [ Time Frame: Baseline and 1 year ]
    Change from baseline in length (height) and head circumference is presented.
  • Change in body weight. [ Time Frame: Baseline and 1 year ]
    Change from baseline in body weight is presented.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open-label
Primary Purpose: Treatment
Condition  ICMJE Infantile Spasms
Intervention  ICMJE Drug: GWP42003-P
Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other Names:
  • CBD
  • Cannabidiol
Study Arms  ICMJE Experimental: GWP42003-P

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.

Intervention: Drug: GWP42003-P
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2016)
202
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02954887
Other Study ID Numbers  ICMJE GWEP15100 Open-label Extension
2015-004904-50 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GW Research Ltd
Study Sponsor  ICMJE GW Research Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GW Research Ltd
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP