The beta-hCG+erythropoietin in acute stroke (BETAS) study: a 3-center, single-dose, open-label, noncontrolled, phase IIa safety trial.

Abstract:

BACKGROUND AND PURPOSE:Animal data suggest the use of beta-human chorionic gonadotropin followed by erythropoietin to promote brain repair after stroke. The current study directly translated these results by evaluating safety of this sequential growth factor therapy through a 3-center, single-dose, open-label, noncontrolled, Phase IIa trial. METHODS:Patients with ischemic stroke 24 to 48 hours old and National Institutes of Health Stroke Scale score of 6 to 24 started a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation). This study also evaluated performance of serially measured domain-specific end points. RESULTS:A total of 15 patients were enrolled. Two deaths occurred, neither related to study medications. No safety concerns were noted among clinical or laboratory measures, including screening for deep vein thrombosis and serial measures of serum hemoglobin. In several instances, domain-specific end points provided greater insight into impairments as compared with global outcome measures. CONCLUSIONS:Results support the safety of this sequential, 2-growth factor therapy initiated 24 to 48 hours after stroke onset.

journal_name

Stroke

journal_title

Stroke

authors

Cramer SC,Fitzpatrick C,Warren M,Hill MD,Brown D,Whitaker L,Ryckborst KJ,Plon L

doi

10.1161/STROKEAHA.109.574343

subject

Has Abstract

pub_date

2010-05-01 00:00:00

pages

927-31

issue

5

eissn

0039-2499

issn

1524-4628

pii

STROKEAHA.109.574343

journal_volume

41

pub_type

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