Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

Summary

The purpose of this study is: * To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control. * To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.

Timeline

Start

2009-08

Primary completion

2010-04

Completion

2010-04

Outcome

Missed primary endpoint

Stopped (Enrollment): “Slow Enrollment”

paper There was no significant difference across treatment groups in the proportion of patients experiencing death, serious adverse events, or any adverse event. PMID 24588854 ↗

paper There was no significant difference in National Institutes of Health Stroke Scale score change from baseline to Day 90 between placebo and active treatment PMID 24588854 ↗

Publications

• Cramer SC, Hill MD; REGENESIS-LED Investigators. Human choriogonadotropin and epoetin alfa in acute ischemic stroke patients (REGENESIS-LED trial). Int J Stroke. 2014 Apr;9(3):321-7. doi: 10.1111/ijs.12260. Epub 2014 Mar 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	4000 iu	Intravenous
Subject	epoetin alfa	Protein / enzyme biologic	12000 iu	Intravenous
Subject	epoetin alfa	Protein / enzyme biologic	20000 iu	Intravenous
Subject	human chorionic gonadotropin	Protein / enzyme biologic	385 ug	Subcutaneous

Indications