Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms (ENACT-2)
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ClinicalTrials.gov Identifier: NCT02056574 |
Recruitment Status :
Withdrawn
First Posted : February 6, 2014
Last Update Posted : August 4, 2015
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Condition or disease | Intervention/treatment | Phase |
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Subarachnoid Hemorrhage Ruptured Intracranial Aneurysm | Drug: NA-1 Drug: Placebo | Phase 2 |
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 |

Arm | Intervention/treatment |
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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.
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Drug: NA-1 |
Placebo Comparator: Placebo
Single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion.
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Drug: Placebo |
- 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.
- 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.
- 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.
- Mortality [ Time Frame: 90 days ]Rate of subarachnoid hemorrhage related mortality over the 90 day study period.
- In-hospital length of stay [ Time Frame: 90 days ]Duration of in-hospital length of stay.

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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.
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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.

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 ClinicalTrials.gov identifier (NCT number): NCT02056574
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 |
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 |
Responsible Party: | NoNO Inc. |
ClinicalTrials.gov 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 |
Endovascular repair Subarachnoid hemorrhage Ruptured intracranial aneurysm |
Stroke Coiling NA-1 |
Subarachnoid Hemorrhage Intracranial Aneurysm Aneurysm Hemorrhage Rupture 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 |