PANGEA
Research type
Research Study
Full title
A double-blind placebo-controlled study with an open-label pilot phase, assessing the efficacy, tolerability and safety of EU-C-001 in patients with moderate to severe traumatic brain injury
IRAS ID
252781
Contact name
Arun Gupta
Contact email
Sponsor organisation
Eustralis Pharmaceuticals Ltd.
Eudract number
2017-004890-15
Duration of Study in the UK
0 years, 10 months, 23 days
Research summary
Traumatic Brain Injury (TBI) is caused by a trauma to the head from a force outside the body, like an accident or fall. Around one million people visit Accident and Emergency each year following a head injury. Although many of these people will experience no lasting effects, others will be left with varying degrees of damage that can have devastating and lifelong consequences.
Moderate head injury is defined as loss of consciousness between 15 minutes and six hours, or a period of post-traumatic amnesia of up to 24 hours. Severe head injury is usually defined as being a condition where the patient has been in an unconscious state for six hours or more, or a post-traumatic amnesia of 24 hours or more.
A common effect of TBI is that it can lead to raised pressure inside the skull, which can have a damaging effect on the brain tissue. When raised pressure inside the skull has been studied in animals, it is thought to be caused in many cases by neurogenic inflammation, which is where neurons (nerve cells) react to the brain injury and stimulate the brain to release certain substances. As a result, an important protective mechanism of the brain, the so-called Blood Brain Barrier, breaks down, liquid moves into the brain and the pressure inside the brain increases, which then causes more damage.
The main purpose of this study is to find out how an investigational new drug (a drug that has not been approved to be prescribed or sold), EU-C-001, affects raised pressure inside the skull in patients with TBI. The study also aims to explore how the drug will affect recovery, how the drug is working, how much is in the blood and cerebrospinal fluid (the fluid in the skull around the brain), and how safe it is in patients with TBI.
When the drug has been given to animals, it has been shown to restore the Blood Brain Barrier, leading to a return to normal pressure in the skull. EU C 001 has been shown to have a good safety profile in animals and in healthy human volunteers.
Eustralis Pharmaceuticals Ltd., trading as PresSura Neuro is the sponsor of this study. There will be approximately 73 patients taking part in Australia, UK and the US.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0027
Date of REC Opinion
5 Jun 2019
REC opinion
Further Information Favourable Opinion