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

Withdrawn

Phase 2 Results N/A

Update History

5 Aug '15
A location was updated in Phoenix.
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The overall status was removed for Barrow Neurological Institute.
A location was updated in Englewood.
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The overall status was removed for Colorado Neurological Institute.
A location was updated in Ann Arbor.
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The overall status was removed for University of Michigan - Neurosurgery.
A location was updated in Portland.
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The overall status was removed for Oregon Health and Science University.
A location was updated in Madison.
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The overall status was removed for University of Wisconsin.
A location was updated in Calgary.
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The overall status was removed for Foothills Medical Centre.
A location was updated in Halifax.
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The overall status was removed for QEII Health Sciences Centre - Halifax Infirmary.
A location was updated in London.
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The overall status was removed for London Health Sciences Centre.
A location was updated in Toronto.
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The overall status was removed for St. Michael's Hospital.
A location was updated in Toronto.
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The overall status was removed for Sunnybrook Health Sciences Centre.
A location was updated in Toronto.
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The overall status was removed for Toronto Western Hospital.
A location was updated in Quebec City.
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The overall status was removed for Hopital de l'Enfant Jesus.
2 Apr '15
The eligibility criteria were updated.
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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.
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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 not requiring the use of antiplatelet agents other than ASA. - 2. Patient should be Grade I-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 ≤ 38.5oC. - 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. Intended use of antiplatelet medications other than ASA for the endovascular repair procedure. - 5. Known history of life-threatening allergic reaction to any medication. - 6. Chronic renal disease defined as a baseline serum creatinine > 150 µmol/L. - 7. Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test. - 8. Women who are breastfeeding. - 9. Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol. - 10. Pre-morbid (estimated) modified Rankin scale score of >1. - 11. Previous major stroke. - 12. Patients with known HIV infection. - 13. Participation in a clinical trial with an investigational drug within 30 days preceding this study. - 14. 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. - 15. 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.