Primary objective: To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.
Secondary objective: To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.
- Epoetin Alfa (Procrit and Epogen)Drug
Other Names: Procrit Intervention Desc: Used to treat anemia, to decrease the need for red blood cell transfusions. Usually given by subcutaneous injection.
- Human chorionic gonadotropin Drug
Intervention Desc: Human chorionic gonadotropin (hCG) is a peptide hormone produced in pregnancy that is made by the embryo soon after conception and later by the syncytiotrophoblast (part of the placenta). Its role is to prevent the disintegration of the corpus luteum of the ovary and thereby maintain progesterone production that is critical for a pregnancy in humans.
- NTx™-265: rhCG, then rEPO Drug
Other Names: Ovidrel; Epogen Intervention Desc: rhCG 10,000 IU, SC, on Day 1, 3, and 5 of study participation, then rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation ARM 1: Kind: Experimental Label: 1
- Saline placebo Drug
Other Names: Sodium Chloride 0.9% Intervention Desc: Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation ARM 1: Kind: Experimental Label: 2
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patient will be randomized to one of two arms. On the drug arm patient will receiv rhCG, then rEPO. rhCG 10,000 IU, SC, on Day 1, 3, and 5 of study participation, then rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation. On the saline placebo arm, the patient will recieve saline SC, on Day 1, 3, and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation. Patient will return for testing in 90 days for mRS, NIHSS, Barthel Index, Action Research Arm Test, Gait Velocity Test, Boston Naming Test, Line cancellation Test and Trails A & B Test.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin Score (mRS); NIHSS response.|
|Secondary||NIHSS; mRS; Barthel Index; Action Research Arm Test; Gait Velocity Test; Boston Naming Test; Line Cancellation Test; Trails A & B Test.|
|Primary||Modified Rankin Score (mRS)||Day 90||No|
|Primary||NIHSS response||Day 90||No|
|Secondary||Barthel Index||Day 90||No|
|Secondary||Action Research Arm Test||Day 90||No|
|Secondary||Gait Velocity Test||Day 90||No|
|Secondary||Boston Naming Test||Day 90||No|
|Secondary||Line Cancellation Test||Day 90||No|
|Secondary||Trails A & B Test||Day 90||No|