Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: human chorionic gonadotropin (hCG), then epoetin alfa (EPO); human chorionic gonadotropin (hCG), then epoetin alfa (EPO); human chorionic gonadotropin (hCG), then epoetin alfa (EPO); Saline Placebo
Intervention description: 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; 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; 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; Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation
Intervention MeSH terms: Epoetin Alfa; Chorionic Gonadotropin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

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

          -  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