Beta-hCG + Erythropoietin in Acute Stroke — BETAS  

Acute Stroke Clinical Trial

Official title: Safety of Beta-hCG + Erythropoietin in Acute Stroke

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke.

Clinical Trial Description

Patients with a new stroke will be evaluated at the University of California Irvine Medical Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian. Standard stroke pathways will be used to identify such patients and to initiate standard of care therapy. Patients potentially eligible for study enrollment will be identified, screened, then consented and enrolled. Those meeting all entry criteria, and no exclusion criteria, will undergo additional baseline testing including brain MRI. A 9-day course of B-E therapy will then begin, always within 48 hours after stroke onset. This therapy will consist of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of study participation), followed by a one day washout period (day 6), followed by Epo (three once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation). Patients will be examined at several time points during therapy, as well as 6 weeks and 3 months after stroke onset. The primary outcome measures are related to safety, while secondary outcome measures are related to disability, neurological status, and MRI measures. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

• NCT number: NCT00362414
• Study type: Interventional
• Source: University of California, Irvine
• Status: Completed
• Phase: Phase 2
• Start date: August 2006
• Completion date: March 2008