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.
- Placebo Drug
Intervention Desc: 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.
- NTx-265 Drug
Intervention Desc: 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.
- NTx™-265: rhCG, then rEPO Drug
Other Names: Ovidrel; Epogen Intervention Desc: rhCG 385 µg, 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
Patients will be randomized to either experimental arm with NTx™-265: rhCG, then rEPO (rhCG 385 µg, 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) or placebo saline IV at same intervals. Then patients will have baseline and 90 day testing using 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|
|Secondary||mRS; NIHSS; Barthel Index; Action Research Arm Test; Gait Velocity Test; Boston Naming Test; Line Cancellation Test; Trails A & B Test.|
|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|