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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2022 |
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Main ID: |
NCT02224703 |
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Date of registration:
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21/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome. |
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Date of first enrolment:
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April 13, 2015 |
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Target sample size:
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199 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02224703 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Israel
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Netherlands
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Poland
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Spain
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United States
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Participant must have been male or female, aged between 2 and 18 years (inclusive).
- Participant must have had a documented history of Dravet syndrome that was not
completely controlled by current antiepileptic drugs.
- Participant must have been taking 1 or more antiepileptic drugs at a dose that had
been stable for at least 4 weeks.
- All medications or interventions for epilepsy (including ketogenic diet and vagus
nerve stimulation) must have been stable for 4 weeks prior to screening and
participant was willing to maintain a stable regimen throughout the study.
Key Exclusion Criteria:
- Participant had clinically significant unstable medical conditions other than
epilepsy.
- Participant had clinically relevant symptoms or a clinically significant illness in
the 4 weeks prior to screening or randomization, other than epilepsy.
- Participant was currently using or had in the past used recreational cannabis,
medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®)
within the 3 months prior to study entry and was unwilling to abstain for the duration
for the study.
- Participant had any known or suspected hypersensitivity to cannabinoids or any of the
excipients of the investigational medicinal products.
- There were plans for the participant to travel outside their country of residence
during the study.
- Any history of suicidal behavior or any suicidal ideation of type four or five on the
Columbia-Suicide Severity Rating Scale (Children's) at screening.
Age minimum:
2 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Dravet Syndrome
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Intervention(s)
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Drug: GWP42003-P
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Drug: Placebo Control
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Primary Outcome(s)
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Change In Convulsive Seizures During The Treatment Period Compared To Baseline
[Time Frame: Baseline to Day 99 or Early Termination (ET)]
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Secondary Outcome(s)
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Change In Total Seizures During The Treatment Period Compared To Baseline
[Time Frame: Baseline to Day 99 or ET]
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Caregiver Global Impression Of Change (CGIC) At The Last Visit
[Time Frame: Baseline to Last Visit]
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Participants With A =50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period
[Time Frame: Baseline to Day 99 or ET]
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Secondary ID(s)
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2014-002939-34
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GWEP1424
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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