NCT02056574

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Typical duration for phase_2

Geographic Reach
2 countries

12 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

August 4, 2015

Status Verified

March 1, 2015

Enrollment Period

4 years

First QC Date

February 4, 2014

Last Update Submit

August 3, 2015

Conditions

Subarachnoid HemorrhageRuptured Intracranial Aneurysm

Keywords

Endovascular repairSubarachnoid hemorrhageRuptured intracranial aneurysmStrokeCoilingNA-1

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale (mRS)

    Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.

    90 days

Secondary Outcomes (4)

  • Modified Rankin Scale (mRS)

    30-45 days

  • National Institutes of Health Stroke Scale (NIHSS)

    90 days

  • Mortality

    90 days

  • In-hospital length of stay

    90 days

Study Arms (2)

NA-1

EXPERIMENTAL

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

PLACEBO COMPARATOR

Single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion.

Drug: Placebo

Interventions

NA-1DRUG
NA-1
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • \. Patient should be Grade II-IV on the WFNS grading scale for SAH.
  • \. Male or female with a minimum age of 18 years on the day of enrolment.
  • \. Female subjects of childbearing potential: Negative pregnancy test.
  • \. 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.
  • \. Body weight less than or equal to 180 kg.
  • \. Vital signs on admission:
  • Blood pressure between 80-180 mm Hg systolic/50-100 mm Hg diastolic;
  • Body temperature ≤ 38.5C.
  • \. Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements.

You may not qualify if:

  • \. Prior SAH within 6 months of presentation.
  • \. Dissecting or mycotic brain aneurysm.
  • \. Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment.
  • \. Known history of life-threatening allergic reaction to any medication.
  • \. Chronic renal disease defined as a baseline serum creatinine \> 150 µmol/L.
  • \. Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.
  • \. Women who are breastfeeding.
  • \. Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.
  • \. Pre-morbid (estimated) modified Rankin scale score of \>1.
  • \. Previous major stroke.
  • \. Patients with known HIV infection.
  • \. Participation in a clinical trial with an investigational drug within 30 days preceding this study.
  • \. 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.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Barrow Neurological Institute

Phoenix, Arizona, 850139, United States

Location

Colorado Neurological Institute

Englewood, Colorado, 801130000, United States

Location

University of Michigan - Neurosurgery

Ann Arbor, Michigan, 481090000, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

University of Wisconsin

Madison, Wisconsin, 537920000, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

QEII Health Sciences Centre - Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Hopital de l'Enfant Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Subarachnoid HemorrhageStroke

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Tymianski, MD, PhD

    NoNO Inc.

    STUDY DIRECTOR

  • Cameron G McDougall, MD

    Barrow Neurological Institute

    PRINCIPAL INVESTIGATOR

  • Michael D Hill, MD

    Foothills Medical Centre

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 6, 2014

Study Start

November 1, 2015

Primary Completion

November 1, 2019

Study Completion

April 1, 2020

Last Updated

August 4, 2015

Record last verified: 2015-03

Locations

CA(7)US(5)