Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults (GWPCARE3)
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ClinicalTrials.gov Identifier: NCT02224560 |
Recruitment Status :
Completed
First Posted : August 25, 2014
Results First Posted : July 27, 2018
Last Update Posted : September 28, 2022
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Sponsor:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Jazz Pharmaceuticals
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Epilepsy Lennox Gastaut Syndrome |
Interventions |
Drug: GWP42003-P Drug: Placebo control |
Enrollment | 225 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | The dose levels of 10 and 20 milligram (mg) per kilogram (kg) per day (mg/kg/day) were recommended by the Data Safety Monitoring Committee (DSMC) of study GWEP1332 Part A (NCT02091206) after assessment of safety and pharmacokinetic data. Participants of GWEP1414 were not enrolled until the DSMC had reviewed the safety data of GWEP1332 Part A. |
Arm/Group Title | GWP42003-P 20 mg/kg/Day Dose | GWP42003-P 10 mg/kg/Day Dose | Placebo |
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Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the open-label extension (OLE) study, the maintenance period was followed by a 10-day taper (10% per day) period. | Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period. | Participants received placebo (0 mg/milliliter [mL] cannabidiol [CBD]), volume matched to 1 of the 2 dose levels (10 or 20 mg/kg/day), administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 7 to 11 days according to the matched investigational medicinal product (IMP) group (7 or 11 days for the 10 or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period. |
Period Title: Overall Study | |||
Started | 76 | 73 | 76 |
Safety Analysis Set [1] | 82 [2] | 67 [2] | 76 |
Intent to Treat (ITT) Analysis Set [3] | 76 | 73 | 76 |
Completed | 67 | 71 | 74 |
Not Completed | 9 | 2 | 2 |
Reason Not Completed | |||
Protocol Deviation | 1 | 0 | 0 |
Withdrawal by Subject | 2 | 0 | 1 |
Met Withdrawal Criteria | 1 | 0 | 0 |
Adverse Event | 4 | 1 | 1 |
Withdrawn by Investigator | 1 | 1 | 0 |
[1]
Received at least 1 dose of IMP; analyzed as per actual treatment received.
[2]
Six participants assigned to the 10 mg/kg/day dose were included in the 20 mg/kg/day group.
[3]
Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement.
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Baseline Characteristics
Arm/Group Title | GWP42003-P 20 mg/kg/Day Dose-ITT Analysis Set | GWP42003-P 10 mg/kg/Day Dose-ITT Analysis Set | Placebo-ITT Analysis Set | Total | |
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Participants received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement; analyzed according to the treatment group to which they were randomized (GWP42003-P 20 mg/kg/day). | Participants received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement; analyzed according to the treatment group to which they were randomized (GWP42003-P 10 mg/kg/day). | Participants received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement; analyzed according to the treatment group to which they were randomized (Placebo). | Total of all reporting groups | |
Overall Number of Baseline Participants | 76 | 73 | 76 | 225 | |
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ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 76 participants | 73 participants | 76 participants | 225 participants | |
16.0 (10.8) | 15.4 (9.5) | 15.3 (9.3) | 15.6 (9.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 76 participants | 73 participants | 76 participants | 225 participants | |
Female |
31 40.8%
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33 45.2%
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32 42.1%
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96 42.7%
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Male |
45 59.2%
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40 54.8%
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44 57.9%
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129 57.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Medical Enquiries |
Organization: | GW Research Ltd |
EMail: | medinfo@gwpharm.com, medinfo@greenwichbiosciences.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jazz Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02224560 |
Other Study ID Numbers: |
GWEP1414 2014-002940-42 ( EudraCT Number ) |
First Submitted: | August 21, 2014 |
First Posted: | August 25, 2014 |
Results First Submitted: | June 25, 2018 |
Results First Posted: | July 27, 2018 |
Last Update Posted: | September 28, 2022 |