Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms "ENACT-2"


Phase 2 Results N/A

Eligibility Criteria

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.