A study to evaluate the efficacy, tolerability and safety of EU-C-001 compared to placebo in patients with moderate to severe brain injury

Phase 1

• Conditions: Traumatic brain injury; MedDRA version: 22.1Level: LLTClassification code 10021665Term: Increased intracranial pressureSystem Organ Class: 100000004852; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2017-004890-15-GB
• Lead Sponsor: Eustralis Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-29
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Male or female aged 18 to 65 years at the time the ICF is signed, or obtained remotely, by either the patient or the patient’s legally authorized representative
2. Moderate to severe TBI due to blunt mechanism
3. Abnormal CT scan result consistent with TBI due to blunt mechanism
4. Intracranial pressure monitor in situ, ICP >20 mm Hg at screening in the absence of potential external ICP stimuli, e.g., suctioning, coughing, and turning. ICP at start of first infusion of study drug = 18 mmHg. The preferred method of ICP measurement is either intraventricular, intraparenchymal, or subdural, where possible
5. The GCS score at Screening is the most recent GCS score assessed at the hospital after resuscitation. If this is not available, the GCS score assessed by the ambulance personnel/paramedics prior to arrival at hospital will be used.
a. If the Total Score is assessable (range 3 to 15), a patient is eligible for inclusion if their score is in the range 3 to 12
b. If only the Eye and Motor scores are assessable (range 2 to 10), a patient is eligible for inclusion if their score is in the range 2 to 8
c. If only the Motor score is assessable (range 1 to 6), a patient is eligible for inclusion if their score is in the range 1 to 5
6. Onset of TBI within the last 72 hours

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Documented continuously elevated ICP >20 mm Hg for >12 hours after elevated ICP was first measured/observed
2.Use of an extraventricular drain (EVD) for ICP control
3. Injury deemed non-survivable by study team
4. Penetrating brain injury
5. Bilateral dilated, unresponsive pupils
6. Imminent cranial or extracranial surgery
7. Concomitant use of thiopentone
8. Cervical spinal cord injury
9. Cardiopulmonary resuscitation performed
10. Life-threatening systemic injuries, additional injuries, or conditions requiring medical treatment which would confound the assessment of the effects and/or safety of study medication
11. Morbid obesity with body mass index =40 kg/m2
12. Severe or unstable pre-existing respiratory and hemodynamic conditions
13. Hypoxemia (oxygen saturation <80%, measured by pulse oximetry)
14. Hypotension (sustained systolic blood pressure <70 mm Hg despite adequate volume resuscitation and vasopressors)
15. Status epilepticus
16. Pregnancy
17. Clinically significant anemia (hemoglobin <7 g/dL)
18. History of blood clotting disorder; exclude if international normalized ratio (INR) >1.5 and/or thrombocytes <50,000/µL
19. Moderate to severe renal impairment with estimated glomerular filtration rate <60 mL/min
20. Hepatic dysfunction with 1 or more of the following liver function test results: total bilirubin >2 x upper limit of normal (ULN), alanine aminotransferase >2.5 x ULN, or aspartate aminotransferase >2.5 x ULN, INR >1.5
21. Any major neurological or psychiatric disorder associated with significant impairment of cognitive function or motor function e.g., Alzheimer’s disease with dementia, Parkinson’s disease, Huntington’s disease, alcohol or substance abuse
22. Participating in or has participated in other investigational interventional studies (drug or device) within the last 30 days (or 5 times the half-life of the previously administered investigational compound, whichever is longer) prior to study treatment initiation
23. Wearing an opt out bracelet or is known not to wish to participate in this type of study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified