Clinical Trials/NCT00938314

NCT00938314

Terminated

Phase 2

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

Stem Cell Therapeutics Corp.23 sites in 3 countries96 target enrollmentAugust 2009

ConditionsStroke

Interventionshuman chorionic gonadotropin (hCG), then epoetin alfa (EPO)Saline Placebo

Drugshuman chorionic gonadotropin (hCG), then epoetin alfa (EPO)Saline Placebo

Overview

Phase: Phase 2
Intervention: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
Conditions: Stroke
Sponsor: Stem Cell Therapeutics Corp.
Enrollment: 96
Locations: 23
Primary Endpoint: National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

April 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stem Cell Therapeutics Corp.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-85
•NIHSS score 8-20
•Stroke is ischemic in origin, supratentorial, and radiologically confirmed
•Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered
•Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits
•Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
•Female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study

Exclusion Criteria

•Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
•Patients who have received tissue plasminogen activator (tPA)following the index stroke
•Patients classified as comatose
•Women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control
•Serum hemoglobin \> 16 grams(g)/deciliter (dL)(males) or \> 14 g/dL (females); or platelet count \> 400,000/cubic millimeters(mm3)
•Advanced liver, kidney, cardiac, or pulmonary disease
•Elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (AST) or alanine transaminase (ALT),creatinine, or prostate-specific antigen (PSA) levels
•Patients with a known history of hypercoagulability
•Expected survival \< 1 year
•Allergy or other contraindication to hCG or EPO

Arms & Interventions

NTx®-265 Low Dose

hCG 385 µg (10,000 international unit \[IU\]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation

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

NTx®-265 Medium Dose

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

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

NTx®-265 High Dose

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

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

Saline Placebo

Intervention: Saline Placebo

Outcomes

Primary Outcomes

National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90

Time Frame: Baseline and Day 90

The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).

Secondary Outcomes

NIHSS Response >=4 at Day 90(Baseline and Day 90)
NIHSS Change From Baseline at Day 30(Baseline and Day 30)
Modified Rankin Scale (mRS) Response <=2 at Day 90(Day 90)
Barthel Index at Day 90(Day 90)
Action Research Arm Test (ARAT) Change From Baseline at Day 90(Baseline and Day 90)
Gait Velocity Test Change From Baseline at Day 90(Baseline and Day 90)
Boston Naming Test (BNT) Change From Baseline at Day 90(Baseline and Day 90)
Line Cancellation Test Change From Baseline at Day 90(Baseline and Day 90)
Trails A Test Change From Baseline at Day 90(Baseline and Day 90)
Trails B Test Change From Baseline at Day 90(Baseline and Day 90)
Geriatric Depression Scale at Day 90(Day 90)