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



Status:Withdrawn
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2015
End Date:April 2020

Use our guide to learn which trials are right for you!

Phase 2, Multicenter Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Patients With Subarachnoid Hemorrhage Undergoing Endovascular Repair of Ruptured Intracranial Aneurysms

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.


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.
We found this trial at
6
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Calgary, Alberta
?
mi
from
Calgary,
Click here to add this to my saved trials
Englewood, Colorado
?
mi
from
Englewood, CO
Click here to add this to my saved trials
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Phoenix, Arizona 85013
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials