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 March 2015 by NoNO Inc.
Sponsor:
Information provided by (Responsible Party):
NoNO Inc.
ClinicalTrials.gov Identifier:
NCT02056574
First received: February 4, 2014
Last updated: March 31, 2015
Last verified: March 2015
  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 2015
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: November 2019 (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, 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.
  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         
United States, Colorado
Colorado Neurological Institute Not yet recruiting
Englewood, Colorado, United States, 801130000
Contact: Ashley Bitner, CCRP         
Principal Investigator: Chamisa Macindoe, MD         
United States, Michigan
University of Michigan - Neurosurgery Not yet recruiting
Ann Arbor, Michigan, United States, 481090000
United States, Oregon
Oregon Health and Science University Not yet recruiting
Portland, Oregon, United States, 97239-3098
Contact: Monica Dolan, RN         
Principal Investigator: Wayne Clark, MD         
United States, Wisconsin
University of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 537920000
Contact: Stephanie Wilbrand         
Principal Investigator: Azam Ahmed, MD         
Canada, Alberta
Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Carol Kenney, RN         
Principal Investigator: John Wong, MD         
Canada, Nova Scotia
QEII Health Sciences Centre - Halifax Infirmary Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Kimberly Hesser, RN         
Principal Investigator: Mel Boulton, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Marlene Santos, MD         
Principal Investigator: Loch Macdonald, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Alex Kostynskyy, MD         
Principal Investigator: Ivan Radovanovic, MD         
Canada, Quebec
Hopital de l'Enfant Jesus Not yet recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Contact: Annette Hache, RN         
Principal Investigator: Genevieve Milot, MD         
Sponsors and Collaborators
NoNO Inc.
Investigators
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
  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: March 31, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on April 26, 2015