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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02056574
Recruitment Status : Withdrawn
First Posted : February 6, 2014
Last Update Posted : August 4, 2015
Information provided by (Responsible Party):
NoNO Inc.

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Ruptured Intracranial Aneurysm Drug: NA-1 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Modified Rankin Scale (mRS) [ Time Frame: 90 days ]
    Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.

Secondary Outcome Measures :
  1. Modified Rankin Scale (mRS) [ Time Frame: 30-45 days ]
    Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the mRS at Day 30-45.

  2. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 90 days ]
    Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 90.

  3. Mortality [ Time Frame: 90 days ]
    Rate of subarachnoid hemorrhage related mortality over the 90 day study period.

  4. In-hospital length of stay [ Time Frame: 90 days ]
    Duration of in-hospital length of stay.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02056574

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United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 850139
United States, Colorado
Colorado Neurological Institute
Englewood, Colorado, United States, 801130000
United States, Michigan
University of Michigan - Neurosurgery
Ann Arbor, Michigan, United States, 481090000
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 537920000
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, Nova Scotia
QEII Health Sciences Centre - Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Hopital de l'Enfant Jesus
Quebec City, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
NoNO Inc.
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Study Director: Michael Tymianski, MD, PhD NoNO Inc.
Principal Investigator: Cameron G McDougall, MD Barrow Neurological Institute
Principal Investigator: Michael D Hill, MD Foothills Medical Centre
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Responsible Party: NoNO Inc. Identifier: NCT02056574    
Other Study ID Numbers: NA-1-006
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: March 2015
Keywords provided by NoNO Inc.:
Endovascular repair
Subarachnoid hemorrhage
Ruptured intracranial aneurysm
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Intracranial Aneurysm
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Wounds and Injuries