Clinical trial NCT02056574: Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Subarachnoid Hemorrhage
Ruptured Intracranial Aneurysm
Keywords: Endovascular repair
Subarachnoid hemorrhage
Ruptured intracranial aneurysm
Stroke
Coiling
NA-1
Lead sponsor: NoNO Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 90 days
Secondary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 30-45 days
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
measure: In-hospital length of stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan - Neurosurgery
state: Michigan
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Halifax
country: Canada
facility: QEII Health Sciences Centre - Halifax Infirmary
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Quebec City
country: Canada
facility: Hopital de l'Enfant Jesus
state: Quebec
Study officials:
affiliation: NoNO Inc.
name: Michael Tymianski, MD, PhD
role: STUDY_DIRECTOR
affiliation: Barrow Neurological Institute
name: Cameron G McDougall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foothills Medical Centre
name: Michael D Hill, MD
role: PRINCIPAL_INVESTIGATOR
References: