| Primary | National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90 | The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). | The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 | Saline Placebo | saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation |
| | Units | Counts |
|---|
| Participants | - OG00024
- OG00124
- OG00224
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0006.79± 4.22
- OG0016.50± 4.53
- OG0026.08± 3.30
- OG003
|
|
| |
| Secondary | NIHSS Response >=4 at Day 90 | The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). NIHSS Response >=4 is defined as a >=4 change from baseline at Day 90. | The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Number | | participants | | Baseline and Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 | Saline Placebo |
|
| Secondary | NIHSS Change From Baseline at Day 30 | The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). | The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 | Saline Placebo | |
|
| Secondary | Modified Rankin Scale (mRS) Response <=2 at Day 90 | The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0 (perfect health without symptoms) to 6 (dead). mRS response <=2 is defined as the mRS score <=2 at Day 90. | The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Number | | participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 | Saline Placebo |
|
| Secondary | Barthel Index at Day 90 | The Barthel Index measures 10 activities of daily living and mobility. A score of 100 = is best (able to live at home with a degree of independence), 0 is worst. | The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | Scores on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 | Saline Placebo | saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation |
|
| Secondary | Action Research Arm Test (ARAT) Change From Baseline at Day 90 | The ARAT assesses recovery of arm function following stroke through a series of subtests judging ability to grasp, grip, pinch, or move the arm; scores are on a scale; The total maximum (best) score is 57 and the total minimum (worst) score is 0. | Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | |
|
| Secondary | Gait Velocity Test Change From Baseline at Day 90 | The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters. | Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | seconds | | Baseline and Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 | Saline Placebo | |
|
| Secondary | Boston Naming Test (BNT) Change From Baseline at Day 90 | The BNT assesses impairment of language ability by asking patients to identify 20 different pictures each time the test is taken. A score of 20 is best, 0 is worst. | Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 | Saline Placebo |
|
| Secondary | Line Cancellation Test Change From Baseline at Day 90 | The Line Cancellation Test detects the loss of awareness of one side of the body. A score of 0.00 (no units) is normal (patient favors neither right nor left side). A score of +1.00 indicates severe unawareness of the left side. A score of -1.00 indicates severe unawareness of the right side. | Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 |
|
| Secondary | Trails A Test Change From Baseline at Day 90 | The Trails A test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 numbers (e.g., 1, 2, 3, 4…) | Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | seconds | | Baseline and Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 | Saline Placebo |
|
| Secondary | Trails B Test Change From Baseline at Day 90 | The Trails B test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 alpha numeric circles (e.g., 1, A, 2, B, 3, C, 4, D) | Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | seconds | | Baseline and Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 |
|
| Secondary | Geriatric Depression Scale at Day 90 | The Geriatric Depression Scale is commonly used to assess depression in stroke patients of any age by asking 15 yes/no questions, and then scored. A score of 0 - 5 is normal, whereas a score of 6 -15 suggests depression. | Not all patients enrolled in the group completed this outcome measure. The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | scores on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | NTx®-265 Low Dose | 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 | | OG001 | NTx®-265 Medium Dose | 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 | | OG002 | NTx®-265 High Dose | 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 | | OG003 |
|