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

This study is currently recruiting participants.
Verified March 2017 by GW Research Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT02953548
First Posted: November 2, 2016
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
GW Research Ltd
  Purpose
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.

Condition Intervention Phase
Infantile Spasms Drug: GWP42003-P Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by GW Research Ltd:

Primary Outcome Measures:
  • Number of participants who experienced a treatment-emergent adverse event. [ Time Frame: 2 weeks ]
    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: 2 weeks ]
    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: 2 weeks ]
    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: 2 weeks ]
    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:
  • Number of treatment responders. [ Time Frame: 2 weeks ]
    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: 2 weeks ]
    The number of participants who are free of clinical spasms is presented.

  • Number of participants without hypsarrhythmia. [ Time Frame: 2 weeks ]
    The number of participants with resolution of hypsarrhythmia is presented.


Estimated Enrollment: 10
Actual Study Start Date: March 16, 2017
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GWP42003-P
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.
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT02953548


Contacts
Contact: GW Research Medical Information +44 (0) 1223 266 800 medinfo@gwpharm.com

Locations
United States, North Carolina
Recruiting
Winston Salem, North Carolina, United States
United States, Tennessee
Not yet recruiting
Memphis, Tennessee, United States
Sponsors and Collaborators
GW Research Ltd
  More Information

Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02953548     History of Changes
Other Study ID Numbers: GWEP15100 Pilot Phase
2015-004904-50 ( EudraCT Number )
First Submitted: November 1, 2016
First Posted: November 2, 2016
Last Update Posted: March 20, 2017
Last Verified: March 2017

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:
Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases