Safety and tolerability of deferoxamine mesylate in patients with acute intracerebral hemorrhage.

ABSTRACT:

Background and purpose

Treatment with the iron chelator, deferoxamine mesylate (DFO), improves neurological recovery in animal models of intracerebral hemorrhage (ICH). We aimed to evaluate the feasibility, safety, and tolerability of varying dose-tiers of DFO in patients with spontaneous ICH, and to determine the maximum tolerated dose to be adopted in future efficacy studies.

Methods

This was a multicenter, phase-I, dose-finding study using the Continual Reassessment Method. DFO was administered by intravenous infusion for 3 consecutive days, starting within 18 hours of ICH onset. Subjects underwent repeated clinical assessments through 90 days, and computed tomography neuroimaging pre- and post-drug-administration.

Results

Twenty subjects were enrolled onto 5 dose

SUBMITTER: Selim M 

PROVIDER: S-EPMC3202043 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature