Ruptured Intracranial Aneurysm, Subarachnoid Hemorrhage
Conditions
Keywords
Endovascular repair, Subarachnoid hemorrhage, Ruptured intracranial aneurysm, Stroke, Coiling, NA-1
Brief summary
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.
Interventions
DRUGNA-1
DRUGPlacebo
Sponsors
NoNO Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. A diagnosis of a ruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, or any neuroendovascular technique such as balloon-assisted coiling, stenting, or flowed diversion. * 2\. Patient should be Grade II-IV on the WFNS grading scale for SAH. * 3\. Male or female with a minimum age of 18 years on the day of enrolment. * 4\. Female subjects of childbearing potential: Negative pregnancy test. * 5\. Non-surgically sterile males or males with partners of childbearing potential must be willing to use condoms with spermicide for 3 months after completion of dosing. * 6\. Body weight less than or equal to 180 kg. * 7\. Vital signs on admission: * Blood pressure between 80-180 mm Hg systolic/50-100 mm Hg diastolic; * Body temperature ≤ 38.5C. * 8\. Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements.
Exclusion criteria
* 1\. Prior SAH within 6 months of presentation. * 2\. Dissecting or mycotic brain aneurysm. * 3\. Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment. * 4\. Known history of life-threatening allergic reaction to any medication. * 5\. Chronic renal disease defined as a baseline serum creatinine \> 150 µmol/L. * 6\. Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test. * 7\. Women who are breastfeeding. * 8\. Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol. * 9\. Pre-morbid (estimated) modified Rankin scale score of \>1. * 10\. Previous major stroke. * 11\. Patients with known HIV infection. * 12\. Participation in a clinical trial with an investigational drug within 30 days preceding this study. * 13\. Previous participation in the ENACT trial (e.g, to treat a prior aneurysm), participation in another trial involving NA-1 or prior receipt of NA-1. * 14\. Any other medical condition that the site investigator deems would put the patient at excessive risk of participation in the study or an expected life expectancy less than 1 year or that would result in inability to collect clinical outcomes at 90 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 90 days | Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 30-45 days | Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the mRS at Day 30-45. |
| National Institutes of Health Stroke Scale (NIHSS) | 90 days | Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 90. |
| Mortality | 90 days | Rate of subarachnoid hemorrhage related mortality over the 90 day study period. |
| In-hospital length of stay | 90 days | Duration of in-hospital length of stay. |
Countries
Canada, United States
Outcome results
None listed