Neonatal Hypoxic-Ischemic Encephalopathy MedDRA version: 21.1 Level: LLT Classification code 10070512 Term: Hypoxic-ischemic encephalopathy System Organ Class: 100000004852 MedDRA version: 21.1 Level: PT Classification code 10050081 Term: Neonatal hypoxia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Current Sponsor code: GWP42003-P
Other descr
Sponsors
GW Research Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient is male or female and > or = 36 weeks of gestational age - Patient is receiving active or passive whole-body cooling/hypothermia since or = 16 mmol/L in umbilical cord or any blood sample (arterial,venous, or capillary) or = 30 minutes’ duration of abnormal background activity on cEEG prior to IMP administration, based on the presence of 1 of the following: • Suppressed activity • Moderately abnormal activity • Seizures of 30 seconds’ duration or more - Patient’s parent(s)/legal representative (if appropriate according to local laws) is/are willing and able to give informed consent for participation in the trial - Patient’s parent(s)/legal representative (if appropriate according to local laws) is/are willing and able (in the PI’s opinion) to comply with all trial requirements - Patient’s parent(s)/legal representative is/are willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law - Patient’s parent(s)/legal representative (if appropriate according to local laws) is/are willing to allow his or her primary care practitioner (if they have one) and consultant (if they have one) to be notified of participation in the trial if the primary care practitioner/consultant is different from the PI Are the trial subjects under 18? yes Number of subjects for this age range: 32 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient’s mother used recreational or medicinal cannabis or synthetic cannabinoid-based medications (including Sativex) within 4 weeks of birth of the patient - IMP cannot be administered within 12 hours of birth and after whole-body hypothermia has been initiated - Patient’s birth weight 3 × upper limit of normal (ULN) - Patient has a genetic or congenital condition that affects neurodevelopment or requires multiple surgeries (e.g., congenital viral infection, hydrops, complex congenital heart disease, severe dysmorphic features, etc.) - Patient has any other significant disease or disorder that, in the opinion of the PI, may put the patient at risk because of participation in the trial, may influence the result of the trial, or may affect the patient’s ability to take part in the trial - Any abnormalities identified following a physical examination of the patient that, in the opinion of the PI, would jeopardize the safety of the patient orinterfere with trial conduct if they took part in the trial - Patient is participating in another interventional trial (note: this does not include observational studies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of a single-ascending intravenous (IV) dose of GWP42003-P compared with placebo in neonates (minimum of 36 weeks plus 0 days gestational age) who are undergoing whole-body hypothermia (standard of care) for the treatment of NHIE;Secondary Objective: To determine the pharmacokinetics (PK) of cannabidiol (CBD) following a single IV dose of GWP42003-P The exploratory objectives of this trial are To assess the efficacy of a single IV dose of GWP42003-P compared with placebo in neonates who are undergoing whole-body hypothermia for the treatment of NHIE with respect to the following: Degree of brain injury/recovery Seizure burden Neurodevelopmental impairment;Primary end point(s): The safety and tolerability profile of a single IV dose of GWP42003-P, compared with placebo, will be assessed through monitoring of the following: • Frequency, type, and severity of adverse events (AEs) up to 30 days of life • Mortality rate up to 30 days of life • Clinically significant changes in the following up to discharge from the neonatal intensive care unit (NICU): o Laboratory parameters o Cardiorespiratory monitoring o Vital signs;Timepoint(s) of evaluation of this end point: Physical and Neurological Exam: Visits 1, 2, 3, 4, 5 and 7. Vital Signs: Hourly from birth to 24 hours postnatal and every 4 hours until 120 hours postnatal Respiratory Support: Every 8 hours from birth until 120 hours postnatal. Safety Laboratory Sampling: Prior to IMP administration, at 36 hours (+/- 12 hours) of life and 72 hours (+/- 12 hours) of life. Clinical Laboratory Sampling: Per routine care throughout hospitalization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The plasma PK of CBD will be investigated. Plasma PK parameters will be determined using a population-based approach with sparse sampling.;Timepoint(s) of evaluation of this end point: PK Samples completed 2 minutes prior to completion of the infusion and at 1, 2, 4 and 8 hours after the end of infusion. | — |
Countries
Poland, Spain, United Kingdom
Contacts
Public ContactGW Research Ltd Switchboard
GW Research Ltd
Outcome results
None listed