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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infantile Spasms Drug: GWP42003-P Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open-label
Primary Purpose: Treatment
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
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arms and Interventions
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Arm Intervention/treatment
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.

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Number of treatment responders. [ Time Frame: 1 year ]
    The number of participants who are free of spasms and have resolution of hypsarrhythmia is presented.

  2. Number of participants who are spasm-free. [ Time Frame: 1 year ]
    The number of participants who are free of clinical spasms is presented.

  3. Number of participants without hypsarrhythmia. [ Time Frame: 1 year ]
    The number of participants with resolution of hypsarrhythmia is presented.

  4. Changes in seizures by subtype. [ Time Frame: 1 year ]
    Changes in seizures by subtype are presented.

  5. 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.

  6. 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.

  7. Number of participants with relapse of spasms. [ Time Frame: 1 year ]
    The number of participants with relapse of spasms is presented.

  8. 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.

  9. Change in length (height) and head circumference. [ Time Frame: Baseline and 1 year ]
    Change from baseline in length (height) and head circumference is presented.

  10. Change in body weight. [ Time Frame: Baseline and 1 year ]
    Change from baseline in body weight is presented.


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954887


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Tennessee
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38103
United States, Virginia
Valley Health Clinical Research
Winchester, Virginia, United States, 22601
Poland
Uniwersyteckie Centrum Kliniczne
Gdańsk, Poland
Centrum Medyczne POMOC
Łódź, Poland
Sponsors and Collaborators
GW Research Ltd
More Information
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Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02954887     History of Changes
Other Study ID Numbers: GWEP15100 Open-label Extension
2015-004904-50 ( EudraCT Number )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GW Research Ltd:
GWP42003-P
Cannabidiol

Additional relevant MeSH terms:
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Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epilepsy, Generalized
 Epilepsy
Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes
Epidiolex
Anticonvulsants