Conditions: Stroke
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 96
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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 arm 2: 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 arm 3: 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 arm 4: None

Interventions: intervention 1: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) intervention 2: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) intervention 3: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) intervention 4: Saline Placebo
Intervention descriptions: intervention 1: 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 intervention 2: 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 3: 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 4: Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation

Protocol document: