Status:
This study is currently recruiting participants.
Purpose:
To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control and to assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.
Interventions:
NTx-265
NTx-265 is a therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin then Erythropoietin, targeting the treatment of stroke. The objective of the regimen is to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke.
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Placebo
A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
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Location(s):
United States, Canada, & India
Year Started:
2009
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
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 forms of contraception throughout the study.
Exclusion Criteria
Patients presenting with lacunar, hemorrhagic and/or brain stem stroke; patients who have received 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 g/dL (males) or > 14 g/dL (females); or platelet count > 400,000/mm3; advanced liver, kidney, cardiac, or pulmonary disease; elevated serum bilirubin,alkaline phosphatase, AST or ALT,creatinine, or PSA levels; patients with a known history of hypercoagulability; expected survival < 1 year;
allergy or other contraindication to hCG or EPO; 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.
Patient Involvement:
Patients will have mRS, NIHSS, Barthel Index, Action Research Arm Test, Gait Velocity Test, Boston Naming Test, Line Cancellation Test, Trails A & B Test, & Geriatric Depression Scale at baseline and 90 days. Patients will be randomized to one of 4 arms: Cohort 1: rhCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then rEPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation, Cohort 2: rhCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then rEPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation, Cohort 3: rhCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then rEPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation, or 4. Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation.
In addition, patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated for their disease state.
Primary Outcome:
Modified Rankin Score; NIHSS response; Adverse events.
Secondary Outcome:
Barthel index; Action Research Arm Test; Gait Velocity Test; Boston Naming Test; Line Cancellation Test; Trails A & B Test; Geriatric Depression Scale.
Source of Information:
ClinicalTrials.gov
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