An international clinical study to compare a new investigational (not yet approved) treatment called EG-1962 to compare against the current standard of care, oral nimodipine, for the improvement of symptoms you may experience after a brain hemorrhage

Phase 1

• Conditions: Aneurysmal subarachnoid hemorrhage (aSAH); MedDRA version: 19.1Level: LLTClassification code 10072200Term: Asymptomatic subarachnoid hemorrhageSystem Organ Class: 100000004863; MedDRA version: 19.1Level: LLTClassification code 10042320Term: Subarachnoid hemorrhageSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-005033-53-CZ
• Lead Sponsor: Edge Therapeutics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-14
• Last Update Posted: 25 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

1. Male or female between the ages of 18 to 75 years, inclusive
2. Ruptured saccular aneurysm confirmed by angiography (catheter, CTA or MRA) and repaired by neurosurgical clipping or endovascular coiling
3. Subarachnoid hemorrhage on computed tomography (CT) scan (pre-repair) of grade 2-4 on the modified Fisher scale (diffuse [clot present in both hemispheres] thick or thin, or local thick)
4. External ventricular drain in place
5. WFNS grade 2, 3, or 4 assessed during the Pre-randomization Phase after repair of the aneurysm but prior to randomization
6. The subject must be able to receive intraventricular IP within 48 hours after the onset of aSAH and within 4 hours after the start time of intraventricular IP suspension in the pharmacy. Onset of aSAH is defined as the time the subject experiences the first symptom of aSAH (e.g., severe headache or loss of consciousness reported either by the subject or by a witness). If found unconscious, the onset of aSAH is defined as the time the subject was last know normal
7. Female subjects of child-bearing potential must have a negative pregnancy test (urine or serum) during the Pre-randomization Phase and must agree to use adequate birth control for at least 30 days following the end of the Treatment Period. Male subjects must agree to use adequate birth control for at least 30 days after the end of the Treatment Period
8. Signed informed consent from the subject or the subject’s legal representative after the completion of aneurysm repair but prior to any study-specific procedures being performed
9. Able and willing to comply with follow up visit schedule

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 249
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

1. Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm
2. Angiographic vasospasm prior to randomization
3. Clinical or radiological evidence of a cerebral infarction with neurological deficit
4. Intracranial pressure >30 mm Hg lasting >4 hours anytime during the Prerandomization Phase
5. Substantial intraventricular hemorrhage
6. Aneurysm repair requiring flow diverting stent or stent-assisted coiling and dual antiplatelet therapy
7. Subject is expected to undergo repair of additional aneurysms within 90 days in cases where multiple aneurysms were identified during the Prerandomization Phase
8. Hemodynamically unstable during the Pre-randomization Phase (i.e., systolic blood pressure (SBP) <100 mm Hg, requiring >6 L colloid, or crystalloid fluid resuscitation)
9. Cardiopulmonary resuscitation required prior to randomization
10. Symptoms or electrocardiogram signs of acute myocardial infarction or unstable angina pectoris prior to randomization
11. Electrocardiogram evidence and/or physical findings compatible with second or third degree heart block or of cardiac arrhythmia associated with hemodynamic instability
12. Echocardiogram, if performed as part of standard of care before randomization, revealing a left ventricular ejection fraction <40%
13. Severe or unstable concomitant condition or disease (e.g., known significant neurologic deficit, cancer, hematologic or coronary disease), or chronic condition (e.g., liver disease, kidney disease or psychiatric disorder), that, in the opinion of the investigator, may increase the risk associated with study participation or IP administration, or may interfere with the interpretation of study results
14. Subjects who have received an investigational product or participated in another interventional clinical study within 30 days prior to randomization. Subjects participating in a non-interventional study that has no bearing on assessment of EG-1962 or enteral nimodipine may be enrolled per guidelines of the local Institutional Review Board/Independent Ethics Committee
15. Known hypersensitivity to nimodipine or other dihydropyridine calcium channel antagonists, poly-D, L-lactide-co-glycolide (PLGA), or hyaluronic acid

Study & Design

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