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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by NoNO Inc.
Sponsor:
Information provided by (Responsible Party):
NoNO Inc.
ClinicalTrials.gov Identifier:
NCT02056574
First received: February 4, 2014
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Subarachnoid Hemorrhage
Ruptured Intracranial Aneurysm
Drug: NA-1
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by NoNO Inc.:

Primary Outcome Measures:
  • Modified Rankin Scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.


Secondary Outcome Measures:
  • Modified Rankin Scale (mRS) [ Time Frame: 30-45 days ] [ Designated as safety issue: No ]
    Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the mRS at Day 30-45.

  • National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 90.

  • Mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Rate of subarachnoid hemorrhage related mortality over the 90 day study period.

  • In-hospital length of stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Duration of in-hospital length of stay.


Estimated Enrollment: 300
Study Start Date: November 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NA-1
20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and an 11 amino acid domain that enables the peptide to cross the blood-brain barrier. Single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion.
Drug: NA-1
Placebo Comparator: Placebo
Single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056574

Contacts
Contact: Roberta Anderson, PhD 613 833 1020 randerson@nonoinc.ca
Contact: Julie Bishop, MA 613 728 0576 jbishop@nonoinc.ca

Locations
United States, Arizona
Barrow Neurological Institute Not yet recruiting
Phoenix, Arizona, United States, 850139
Contact: Cheryl Kelly, RN       cheryl.kelly@dignityhealth.org   
Principal Investigator: Cameron G McDougall, MD         
Sponsors and Collaborators
NoNO Inc.
Investigators
Study Director: Michael Tymianski, MD, PhD NoNO Inc.
Principal Investigator: Cameron G McDougall, MD Barrow Neurological Institute
  More Information

No publications provided

Responsible Party: NoNO Inc.
ClinicalTrials.gov Identifier: NCT02056574     History of Changes
Other Study ID Numbers: NA-1-006
Study First Received: February 4, 2014
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NoNO Inc.:
Endovascular repair
Subarachnoid hemorrhage
Ruptured intracranial aneurysm
Stroke
Coiling
NA-1

Additional relevant MeSH terms:
Intracranial Aneurysm
Aneurysm
Hemorrhage
Subarachnoid Hemorrhage
Aneurysm, Ruptured
Rupture
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Intracranial Hemorrhages
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014