An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol
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|ClinicalTrials.gov Identifier: NCT02564952|
Recruitment Status : Completed
First Posted : October 1, 2015
Results First Posted : September 11, 2018
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: GWP42003-P Drug: Clobazam||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol (GWP42003-P)|
|Actual Study Start Date :||March 11, 2016|
|Actual Primary Completion Date :||June 7, 2017|
|Actual Study Completion Date :||June 7, 2017|
Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.
Clobazam (CLB) was administered in line with the physician's preferred CLB dosing regimen for each participant.
GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants received up to a maximum of 30 mg/kg/day.
Participants were taking CLB upon entry into the OLE phase of the trial. CLB was not an investigational medicinal product (IMP) for the OLE phase and was not administered by the Sponsor, but was administered at the physician's discretion, as required for each participant. CLB could be stopped, if clinically indicated, without impact on analysis.
Other Name: CLB
- Number Of Participants Who Experienced Severe OLE-Emergent AEs [ Time Frame: Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP) ]
An OLE-emergent AE was defined as an AE with an onset date after the first dose of IMP in the OLE phase of the study. The number of participants who experienced 1 or more severe OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 [± 3] days following the last dose of IMP) is presented.
A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
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): NCT02564952
|Barcelona, Spain, 08035|
|Barcelona, Spain, 08036|
|Birmingham, United Kingdom, B15 2FG|
|Brighton, United Kingdom, BN2 5BE|
|Leeds, United Kingdom, LS1 3EX|
|Salford, United Kingdom, M6 8HD|