GW GWEP1560 NHIE CBD IV
Research type
Research Study
Full title
A Randomized, Double blind, Placebo controlled Single ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of GWP42003-P in Conjunction with Hypothermia in Neonates with Moderate or Severe Hypoxic Ischemic Encephalopathy
IRAS ID
256518
Contact name
Suresh Victor
Contact email
Sponsor organisation
GW Research Ltd.
Eudract number
2016-000936-17
Duration of Study in the UK
1 years, 8 months, 24 days
Research summary
Summary of Research
Sometimes during birth, infants are stressed and don’t receive as much oxygen as they need (called asphyxia). When this happens, the infant may have brain injury. The presence of any brain injury at birth is called neonatal hypoxic ischemic encephalopathy (NHIE) and there can be long-term devastating consequences (for example; seizures and cerebral palsy). This study will investigate a new medication in infants diagnosed with NHIE that has been shown in animal studies to reduce brain injury after asphyxia. Infants will be considered for the study if they have moderate to severe NHIE and their doctor has decided to treat the infant by decreasing their body temperature with a cooling blanket, also known as therapeutic hypothermia. During the study four different doses of the medication will be given to determine the best and safest dose. The study will start at the lowest dose and only increase to a higher dose if the preceding dose is determined to be safe. Infants in the study will have blood drawn to determine the level of the study medication in their blood and to test for safety. The electrical activity in the infant’s brain will also be monitored by a non-invasive device on top of their head. Infants will be in the study during their entire stay in the neonatal intensive care unit (NICU). The parents will be asked to answer questions about seizures and development when the infant is 6 months and 1 year old. The primary part of the study will take place in NICUs in England and a total of 32 infants will participate in the study over a two-year study period.
Summary of Results
Conclusions:
GWP42003-P was well tolerated, and there were no new or unexpected safety findings. The dose range of 0.1 to 1.0 mg/kg, administered IV for 15 minutes via continuous infusion in the participants, was not associated with complications, and all 13 participants (9 on GWP42003-P and 4 on placebo) achieved the protocol-defined target dose for the first 3 cohort groups, respectively.Link to results - https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfatiYvtk1-2B2gi1K6vKImual9G6VG4-2FeFhNKGHEnJKTVStcerk2OLhFa4EmeQgICvW75WNpCHDH8IFhVsBmKuy7ytxil_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLHDKSBO7yqaPbHrrY4kX02mSF07wkmJkS2hjs-2By7sbRuX09AKif54OtkGCGpwGMhK97cBWk4Jrb3-2BehISQz-2BRpbUza-2F9X0dUHGIqJwVJWicxuaYb8lWk5aDRmeNoU5crFpbiGAAUPgirkqejXMQoDDjRrKWuDfc4PNe7Wayok4Ew-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C28966a3e38ee4ecebb3b08daf4f063d9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638091610544948180%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=4YpRlNkt7Vr89ENdhkPw5su0vsDNal5sk8SAhZtIfoo%3D&reserved=0
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0295
Date of REC Opinion
23 Jul 2019
REC opinion
Further Information Favourable Opinion