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Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
This study has been completed.
Sponsor:
Hope Pharmaceuticals
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Hope Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00873015
First received: March 31, 2009
Last updated: May 9, 2017
Last verified: May 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Subarachnoid Hemorrhage | Drug: Sodium nitrite Drug: Saline | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant Primary Purpose: Treatment |
| Official Title: | Safety and Pharmacokinetic Evaluation of Sodium Nitrite Injection for the Prevention of Post-Subarachnoid Hemorrhage Induced Vasospasm |
Resource links provided by NLM:
MedlinePlus related topics:
Bleeding
Drug Information available for:
Sodium nitrite
U.S. FDA Resources
Further study details as provided by Hope Pharmaceuticals:
Primary Outcome Measures:
- Mean Plasma Nitrite Concentration (Micromol/L) [ Time Frame: multiple time points up to the end of day 14 ]Samples for pharmacokinetic analysis were collected from subjects treated with sodium nitrite at -15, -5, 0, 10, 30, 60, and 90 minutes after starting nitrite infusion and then at 2, 4, 6, 8, 12, 24, and every 24 hours after starting nitrite infusion. The sample at the time of starting the infusion was considered to be the time 0 sample. On study day 14 additional blood samples were collected at 0, 10, 30, 60, and 90 minutes and at 2, 4, 6, 8, and 12 hours after stopping nitrite infusion. Blood samples were analyzed for nitrite levels using mass spectroscopy.
Secondary Outcome Measures:
- Safety of a 14 Day Infusion of Sodium Nitrite [ Time Frame: 14 days ]
- Efficacy of 14 Day Infusion of Sodium Nitrite [ Time Frame: 14 days ]
| Enrollment: | 19 |
| Study Start Date: | April 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nitrite
Continuous intravenous infusion of Sodium Nitrite
|
Drug: Sodium nitrite
14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
Other Name: Sodium Nitrite Injection NDC 60267-311-10
|
|
Placebo Comparator: Vehicle control
Continuous intravenous infusion of saline
|
Drug: Saline
14 day continuous infusion of a vehicle control infusion
Other Name: Sterile saline
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ruptured cerebral aneurysm
Exclusion Criteria:
- Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00873015
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873015
Locations
| United States, Virginia | |
| University of Virginia Health System Medical Center | |
| Charlottesville, Virginia, United States, 22903 | |
Sponsors and Collaborators
Hope Pharmaceuticals
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
| Principal Investigator: | Edward Oldfield, MD | University of Virginia |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hope Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00873015 History of Changes |
| Other Study ID Numbers: |
14024 1R44NS063485-01 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | March 31, 2009 |
| Results First Received: | January 26, 2013 |
| Last Updated: | May 9, 2017 |
Keywords provided by Hope Pharmaceuticals:
|
Cerebral aneurysm Subarachnoid hemorrhage Nitrite |
Additional relevant MeSH terms:
|
Hemorrhage Subarachnoid Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 23, 2017