NIH STROKENET: ACUTE INTERVENTIONAL STROKE TRIALS
STUDY OF DEFEROXAMINE MESYLATE IN INTRACEREBRAL HEMORRHAGE
The focus of this study is to evaluate the investigational drug, deferoxamine mesylate or deferoxamine. This drug removes iron. Blood in the brain after a brain hemorrhage contains iron and this iron damages the brain. We are studying whether removal of iron from the brain hemorrhage will reduce the effects of the brain hemorrhage. We will look specifically at a person’s ability to function well and to think well after a brain hemorrhage. We will also learn more about the safety of the investigational drug.
Trial Design Summary:
This is a prospective, multi-center, double-blind, randomized, placebo-controlled, phase II, clinical trial. The main objectives are:
- To assess whether it is futile to move the iron chelator deferoxamine mesylate forward as a therapeutic intervention for intracerebral hemorrhage (ICH) into Phase III evaluation
- To assess the safety of deferoxamine intravenous infusions (at a dose of 32 mg/kg/day), given for 3 consecutive days, in a large cohort of ICH patients
Approximately 294 subjects with spontaneous ICH will be randomized within 24 hours of ICH onset to receive either deferoxamine or placebo for 3 consecutive days. Randomization will control for baseline ICH score; ICH onset-to-treatment time; baseline ICH volume; baseline NIHSS; and concurrent use of warfarin at ICH onset. The proportion of subjects with good outcome at 90 days in deferoxamine-treated subjects will be compared to that of placebo-treated subjects in a futility analysis. Good functional outcome will be defined as modified Rankin Scale score of 0-2.
Study Sponsor and Chair: Magdy Selim, MD,PHD Beth Israel Deaconess Medical Center
US FDA, CDER: IND # 77,306
For More Information:
- ClinicalTrials.gov Identifier: NCT02175225 for more information Link: http://clinicaltrials.gov/ct2/show/NCT02175225?
- Questions: Magdy Selim, MD, PhD (firstname.lastname@example.org)