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

NCT ID: NCT02056574

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-04-30

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.

Conditions

Subarachnoid Hemorrhage; Ruptured Intracranial Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

NA-1

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

NA-1

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NoNO Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Tymianski, MD, PhD

Role: STUDY_DIRECTOR

NoNO Inc.

Cameron G McDougall, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurological Institute

Michael D Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Foothills Medical Centre

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Colorado Neurological Institute

Englewood, Colorado, United States

University of Michigan - Neurosurgery

Ann Arbor, Michigan, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Wisconsin

Madison, Wisconsin, United States

Foothills Medical Centre

Calgary, Alberta, Canada

QEII Health Sciences Centre - Halifax Infirmary

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Hopital de l'Enfant Jesus

Québec, Quebec, Canada

Countries

United States; Canada

Other Identifiers

NA-1-006

Identifier Type: -

Identifier Source: org_study_id