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

NCT00938314 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2011-11-29

Study results available
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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.

Conditions

Interventions

DRUG

human chorionic gonadotropin (hCG), then epoetin alfa (EPO)

hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation

DRUG

human chorionic gonadotropin (hCG), then epoetin alfa (EPO)

hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation

DRUG

human chorionic gonadotropin (hCG), then epoetin alfa (EPO)

hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation

DRUG

Saline Placebo

Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation

Sponsors & Collaborators

  • Stem Cell Therapeutics Corp.

    lead INDUSTRY

Principal Investigators

  • Steven C Cramer, MD · Department of Neurology, University of California, Irvine Medical Center

  • Michael D Hill, MD · Department of Clinical Neurosciences, University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States
  • Canada
  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00938314 on ClinicalTrials.gov