A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS)

Stem Cell Therapeutics Corp.26 sites in 2 countries134 target enrollmentMarch 2008

ConditionsStroke

InterventionsSaline placebo

DrugsNTx™-265: rhCG, then rEPO Saline placebo

Overview

Phase: Phase 2
Intervention: Saline placebo
Conditions: Stroke
Sponsor: Stem Cell Therapeutics Corp.
Enrollment: 134
Locations: 26
Primary Endpoint: Modified Rankin Score (mRS)
Status: Terminated
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective: To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.

Secondary objective: To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

January 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stem Cell Therapeutics Corp.

Eligibility Criteria

Inclusion Criteria

•NIHSS score 6-24 within 24-48 hours after stroke onset and enrolment.
•Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment.
•Patient is 24-48 hours from time of stroke onset when the first dose of NTxTM-265 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self-reported to be normal.
•Reasonable expectation of availability to receive the full 9 day NTxTM-265 course of therapy, and to be available for subsequent follow-up visits.
•Reasonable expectation that patient will receive standard post-stroke physical, occupational and speech therapy as indicated.
•Female patient is either:
•Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy) or
•If of childbearing potential, agrees to use two of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits:
•Condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (e.g., implants, injectables, combined oral, etc) OR
•A vasectomised partner OR