An international clinical study to compare a new investigational (not yetapproved) treatment called EG-1962 to compare against the currentstandard of care, oral Nimodipine, for the improvement of symptoms youmay experience after a brain hemorrhage.
- Conditions
- Aneurysmal subarachnoid hemorrhage (aSAH)MedDRA version: 19.1Level: LLTClassification code 10072200Term: Asymptomatic subarachnoid hemorrhageSystem Organ Class: 100000004863MedDRA version: 19.1Level: LLTClassification code 10042320Term: Subarachnoid hemorrhageSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-005033-53-DK
- Lead Sponsor
- Edge Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 374
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 (prerepair)
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 known 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 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 262
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112
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. Increased intracranial (ICP) pressure >30 mm Hg lasting >4 hours
anytime during the Prerandomization Phase
5. Substantial intraventricular hemorrhage XML File Identifier: VEXf+8u4fMzYuKwngc4kWLH47P4= Page 15/31
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 Pre-randomization 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 was required during the Prerandomization
Phase
10. Symptoms or electrocardiogram (ECG) 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 (IRB)/Independent Ethics Committee (IEC)
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method