ClinicalTrials.Veeva

Menu

Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm

H

Hope Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Subarachnoid Hemorrhage

Treatments

Drug: Sodium nitrite
Drug: Saline

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT00873015
14024
1R44NS063485-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.

Full description

Intravenous sodium nitrite has been shown to prevent and to reverse cerebral vasospasm in a primate model of subarachnoid hemorrhage (SAH). This was a Phase IIA dose escalation study of sodium nitrite to determine its safety in patients with aneurysmal SAH and to establish its pharmacokinetics during a 14 day infusion.

Sodium nitrite was delivered intravenously for 14 days in 18 patients with SAH from a ruptured cerebral aneurysm using a dose escalation scheme in three cohorts of 6 patients each (3 nitrite, 3 saline), with a maximum dose of 64 nmol/min/kg. Sodium nitrite blood levels were frequently sampled and measured using mass spectroscopy and blood methemoglobin levels were continuously monitored using a pulse oximeter.

Enrollment

19 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ruptured cerebral aneurysm

Exclusion criteria

  • Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

19 participants in 2 patient groups, including a placebo group

Nitrite
Experimental group
Description:
Continuous intravenous infusion of Sodium Nitrite
Treatment:
Drug: Sodium nitrite
Vehicle control
Placebo Comparator group
Description:
Continuous intravenous infusion of saline
Treatment:
Drug: Saline

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems