This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will be randomized in a 4:1 ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of stiripentol (STP) or valproate (VPA) may be altered (increased or decreased) as a result of using GWP42003-P.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
35
Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Clear, colorless to yellow solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
SEIN - Epilepsy Institute in the Netherlands Foundation
Zwolle, Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Ruber Internacional
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Maximum plasma concentration (Cmax) of STP, VPA, cannabidiol (CBD).
The Cmax of STP, VPA and CBD is presented.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Time to the maximum plasma concentration (Tmax) of STP, VPA and CBD.
The Tmax of STP, VPA and CBD is presented.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Area under the curve (AUC) from zero to final time of positive detection (0-t) of STP, VPA and CBD.
The AUC(0-t) of STP, VPA and CBD is presented.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Area under the plasma concentration time curve over a dosing interval, where tau is the dosing interval [AUCtau].
The AUC(tau) of STP, VPA, and CBD is presented.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Number of participants who experienced an adverse event.
The number of participants who experienced an adverse event during the trial is presented.
Time frame: Up to 11 weeks.
Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).
The number of participants with a clinically significant change in ECG is presented.
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in serum biochemistry.
The number of participants with a clinically significant change in serum biochemistry is presented.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sahlgrenska University Hospital
Gothenburg, Sweden
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in hematology.
The number of participants with a clinically significant change in hematology is presented.
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in urinalysis.
The number of participants with a clinically significant change in urinalysis is presented.
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in vital signs.
The number of participants with a clinically significant change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) is presented.
Time frame: Up to 7 weeks.
Number of participants with a clinically significant change in physical examination.
The number of participants with a clinically significant change in physical examination is presented.
Time frame: Up to 7 weeks.
Number of participants with a treatment-emergent suicidality flag.
Suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). The number of participants with a treatment-emergent flag is presented.
Time frame: Up to 7 weeks.
Seizure frequency by subtype.
The frequency of each subtype of seizure at baseline and end of treatment is presented.
Time frame: Up to 6 weeks.
Number of participants with a treatment-emergent finding indicative of drug abuse liability.
Abuse liability was assessed through monitoring of triggering adverse events of interest and study medication accountability discrepancies. Any findings were assigned to an appropriate classification by the investigator. The number of participants with a treatment-emergent finding indicative of drug abuse liability is presented.
Time frame: Up to 7 weeks.
Cmax of 4-ene-VPA, clobazam (CLB), N-desmethylclobazam (N-CLB), levetiracetam (LEV), and topiramate (TOP).
The Cmax of 4-ene-VPA, CLB, N-CLB, LEV, and TOP is presented.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
Tmax of 4-ene-VPA, CLB, N-CLB, LEV, and TOP.
The Tmax of 4-ene-VPA, CLB, N-CLB, LEV, and TOP is presented.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
AUC(0-t) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP.
The AUC(0-t) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP is presented.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.
AUC(tau) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP.
The AUC(tau) of 4-ene-VPA, CLB, N-CLB, LEV, and TOP is presented.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.