NCT00715364WithdrawnPhase 2
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
Stem Cell Therapeutics Corp.2 sites in 1 country30 target enrollmentStarted: August 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Stem Cell Therapeutics Corp.
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Adverse events
Study Overview
Brief Summary
To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.
To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 NTx™-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 NTx™-265 course of therapy, and to be available for 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, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, 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: i) condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (e.g. implants, injectables, combined oral, etc.) OR ii) a vasectomized partner OR iii) abstinence
Exclusion Criteria
- •Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
- •Patients classified as comatose, defined as a patient who requires repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS 1A score must be <2)
- •Women who have tested positive for pregnancy, or are breast-feeding, or are not using a highly effective method of birth control that can be maintained for the duration of the study
- •Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females); or platelet count > 400,000/mm3
- •Advanced liver, kidney, cardiac, or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher)
- •Serum bilirubin > 1.5 x ULN
- •Alkaline phosphatase > 2.5 x ULN
- •AST or ALT > 2.5 x ULN
- •Creatinine > 2.0 x ULN
- •Patients with known and documented Transferrin saturation <20% or ferritin < 100 ng/ml
- •Patients with known and documented elevated PSA levels
- •Patients with a known history of hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome
- •Expected survival < 1 year
- •Allergy or other contraindication to hCG
- •Allergy or other contraindication to epoetin alfa:
- •A known diagnosis of cancer (except non-malignant skin cancer)
- •Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy
- •Use of either hCG or epoetin alfa within the previous 90 days
- •Any condition known to elevate hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor
- •Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS) ≥ 2
- •Any patients living in a nursing home or supervised living center. Patients must be historically fully independent in all activities of daily living including banking, shopping, cooking, toileting, showering and dressing
- •Any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial
- •With the exception of the qualifying stroke, any other stroke within the previous 3 months
- •Patients who cannot take anti-platelet or anti-coagulant therapy
- •Pre-existing and active major psychiatric or other chronic neurological disease
- •Consume, on average, greater than 14 alcoholic drinks per week, or have a history of substance abuse or dependency within 12 months prior to the study
- •Currently participating in another investigational study
Arms & Interventions
2
Placebo Comparator
Intervention: Saline Placebo (Drug)
Outcomes
Primary Outcomes
Adverse events
Time Frame: screening to Day 90
Secondary Outcomes
- mRS(Day 90)
- NIHSS(Day 90)
- Barthel Index(Day 90)
- Action Research Arm Test(Day 90)
- Gait Velocity Test(Day 90)
- Boston Naming Test(Day 90)
- Line Cancellation Test(Day 90)
- Trails A & B Test(Day 90)
Investigators
Study Sites (2)
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