Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)
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ClinicalTrials.gov Identifier: NCT02091375 |
Recruitment Status :
Completed
First Posted : March 19, 2014
Results First Posted : July 20, 2018
Last Update Posted : August 27, 2018
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Sponsor:
GW Research Ltd
Information provided by (Responsible Party):
GW Research Ltd
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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 Dravet Syndrome |
Interventions |
Drug: GWP42003-P 20 mg/kg/day Dose Drug: Placebo control |
Enrollment | 120 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Baseline Characteristics
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Medical Enquires |
Organization: | GW Research Ltd. |
EMail: | medinfo@gwpharm.com, medinfo@greenwichbiosciences.com |
Responsible Party: | GW Research Ltd |
ClinicalTrials.gov Identifier: | NCT02091375 History of Changes |
Other Study ID Numbers: |
GWEP1332 Part B 2014-002941-23 ( EudraCT Number ) |
First Submitted: | March 17, 2014 |
First Posted: | March 19, 2014 |
Results First Submitted: | June 25, 2018 |
Results First Posted: | July 20, 2018 |
Last Update Posted: | August 27, 2018 |