NCT00938314TerminatedPhase 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 enrollmentStarted: August 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Stem Cell Therapeutics Corp.
- Enrollment
- 96
- Locations
- 23
- Primary Endpoint
- National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90
Study 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.
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
- •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
- •A known diagnosis of cancer in the previous 5 years
- •Uncontrolled hypertension
- •Use of either hCG or epoetin alfa within the previous 90 days
- •Any condition known to elevate hCG
- •Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS)≥ 2
- •Any patients not living independently
- •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
- •Alcohol abuse or have a history of substance abuse or dependency within 12 months prior to the study
- •Currently participating in another investigational study
Arms & Interventions
NTx®-265 Low Dose
Experimental
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) (Drug)
NTx®-265 Medium Dose
Experimental
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) (Drug)
NTx®-265 High Dose
Experimental
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) (Drug)
Saline Placebo
Placebo Comparator
Intervention: Saline Placebo (Drug)
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)
Investigators
Study Sites (23)
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