Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm

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

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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