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

Subarachnoid Hemorrhage Clinical Trial

— ENACT-2  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02056574
• Other study ID #: NA-1-006
• Status: Withdrawn
• Phase: Phase 2
• First received: February 4, 2014
• Last updated: August 3, 2015
• Start date: November 2015
• Est. completion date: April 2020

Study information

• Verified date: March 2015
• Source: NoNO Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (ß-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Intracranial Aneurysm
• Rupture
• Ruptured Intracranial Aneurysm
• Subarachnoid Hemorrhage

Intervention

Drug:
• NA-1

• Placebo

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	QEII Health Sciences Centre - Halifax Infirmary	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	Hopital de l'Enfant Jesus	Quebec City	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
United States	University of Michigan - Neurosurgery	Ann Arbor	Michigan
United States	Colorado Neurological Institute	Englewood	Colorado
United States	University of Wisconsin	Madison	Wisconsin
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
NoNO Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale (mRS)	Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.	90 days	No
Secondary	Modified Rankin Scale (mRS)	Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the mRS at Day 30-45.	30-45 days	No
Secondary	National Institutes of Health Stroke Scale (NIHSS)	Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 90.	90 days	No
Secondary	Mortality	Rate of subarachnoid hemorrhage related mortality over the 90 day study period.	90 days	No
Secondary	In-hospital length of stay	Duration of in-hospital length of stay.	90 days	No