Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage

NCT02176837 | Terminated Phase 2 Results DMC

• 1 other identifier: SN-03-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral aneurysm.

Conditions

Subarachnoid Hemorrhage

Keywords

subarachnoid hemorrhage; vasospasm; nitrite; sodium nitrite

Outcome Measures

Primary Outcomes (1)

• Cerebral Vasospasm

  Cerebral digital subtraction angiographies will be reviewed at at least 2 time points, including at the time of diagnosis of angiographic vasospasm immediately before treatment with nitrite and after up to 180 minutes of nitrite infusion. Radiographs will be compared to determine whether increased flow of radiographic dye is visualized following initiation of nitrite infusion.

  180 minutes

Study Arms (1)

Sodium Nitrite

EXPERIMENTAL

One dose cohort is planned, 64 nmol/min/kg sodium nitrite (0.1325 mg/hour/kg; 0.0442 ml/hour/kg at a concentration of 3mg/ml).

Drug: Sodium Nitrite

Interventions

Sodium Nitrite DRUG

Subjects will receive continuous intravenous infusion of study drug for 7 days at a dose of 64 nmol/min/kg. The infusion will begin shortly after angiographic demonstration of cerebral vasospasm and will be for 7 days unless side effects of the drug dictate stopping the infusion.

Also known as: Sodium Nitrite Injection 300 mg/10 mL

Sodium Nitrite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained from a patient or legal representative before enrollment;
• Admission to hospital following subarachnoid hemorrhage;
• Aneurysm confirmed by digital subtraction angiography or CT-angiography after admission;
• Development of the clinical symptoms and /or signs of cerebral vasospasm and CT-angiography results warranting cerebral angiography.

You may not qualify if:

• Rupture of a fusiform, traumatic, or mycotic aneurysm;
• Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding;
• Methemoglobin \> 2%
• History of sickle cell disease, thalassemia, or other hemoglobinopathy;
• Anemia with hemoglobin level less than 6 g/dL;
• Significant acute or chronic concomitant diseases (including renal, hepatic, cardiovascular, pulmonary, or oncologic disease, sepsis, pulmonary edema, pulmonary embolism) that would be inconsistent with survival for at least 6 months;
• History of allergy to nitrites or allergy to other substances that could interfere with nitrite metabolism, within 30 days before screening;
• History of red blood cell glucose-6-phosphate dehydrogenase (G6PD)deficiency;
• Treatment with allopurinol, a medication that could interfere with nitrite metabolism, within 30 days before screening;
• Other investigational drug within the past 30 days;
• other cerebral injury within the past 30 days including previous subarachnoid hemorrhage, stroke, transient ischemic attacks (TIA), concussion, head trauma, cranial surgery, radiation therapy to the head.

Sponsors & Collaborators

• Hope Pharmaceuticals: lead

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrites; Nitrous Acid; Nitrogen Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Craig Sherman, MD
• Organization: Hope Pharmaceuticals

sherman@hopepharm.com

4806071970

Study Officials

• Kenny Liu, MD

  University of Virginia Medical Center, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: January 15, 2017
• Study Completion: January 15, 2017
• Last Updated: March 30, 2018
• Results First Posted: February 8, 2018

Record last verified: 2018-03

Locations

US (1)