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Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00938314
Recruitment Status : Terminated (Slow Enrollment)
First Posted : July 13, 2009
Results First Posted : November 9, 2011
Last Update Posted : November 29, 2011
Sponsor:
Information provided by (Responsible Party):
Stem Cell Therapeutics Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Stroke
Interventions Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
Drug: Saline Placebo
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Placebo
Hide Arm/Group Description human chorionic gonadotropin (hCG) 385 µg (10,000 international unit [IU]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then epoetin alfa (EPO) 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation 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 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 saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Period Title: Cohort 1
Started 24 0 0 8
Completed 22 0 0 6
Not Completed 2 0 0 2
Period Title: Cohort 2
Started 0 24 0 8
Completed 0 18 0 6
Not Completed 0 6 0 2
Period Title: Cohort 3
Started 0 0 24 8
Completed 0 0 20 7
Not Completed 0 0 4 1
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo Total
Hide Arm/Group Description 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 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 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 saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation Total of all reporting groups
Overall Number of Baseline Participants 24 24 24 24 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 24 participants 96 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  87.5%
17
  70.8%
17
  70.8%
12
  50.0%
67
  69.8%
>=65 years
3
  12.5%
7
  29.2%
7
  29.2%
12
  50.0%
29
  30.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 24 participants 24 participants 96 participants
57.42  (10.49) 58.58  (13.32) 54.83  (12.98) 61.67  (12.38) 58.13  (12.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 24 participants 24 participants 96 participants
Female
18
  75.0%
14
  58.3%
17
  70.8%
16
  66.7%
65
  67.7%
Male
6
  25.0%
10
  41.7%
7
  29.2%
8
  33.3%
31
  32.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 24 participants 24 participants 24 participants 24 participants 96 participants
Canada 0 2 0 0 2
India 24 22 24 24 94
1.Primary Outcome
Title National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90
Hide Description 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).
Time Frame Baseline and Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: scores on a scale
6.79  (4.22) 6.50  (4.53) 6.08  (3.30) 7.17  (4.24)
2.Secondary Outcome
Title NIHSS Response >=4 at Day 90
Hide Description 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.
Time Frame Baseline and Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 24 24 24 24
Measure Type: Number
Unit of Measure: participants
No Response (<4) 6 7 5 5
Response (>=4) 18 17 19 19
3.Secondary Outcome
Title NIHSS Change From Baseline at Day 30
Hide Description 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).
Time Frame Baseline and Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: scores on a scale
4.67  (4.53) 4.29  (3.37) 5.00  (2.98) 5.33  (3.33)
4.Secondary Outcome
Title Modified Rankin Scale (mRS) Response <=2 at Day 90
Hide Description 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.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 24 24 24 24
Measure Type: Number
Unit of Measure: participants
response (mRS <=2) 11 11 15 18
No response (mRS > 2) 13 13 9 6
5.Secondary Outcome
Title Barthel Index at Day 90
Hide Description 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.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 22 18 20 19
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
68.18  (29.62) 80.17  (22.04) 85.25  (20.28) 90.89  (12.69)
6.Secondary Outcome
Title Action Research Arm Test (ARAT) Change From Baseline at Day 90
Time Frame Baseline and Day 90
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 6 6 3 4
Mean (Standard Deviation)
Unit of Measure: scores on a scale
10.67  (13.37) 33.50  (26.12) 30.33  (16.80) 23.75  (20.27)
7.Secondary Outcome
Title Gait Velocity Test Change From Baseline at Day 90
Hide Description The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.
Time Frame Baseline and Day 90
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 4 3 5 5
Mean (Standard Deviation)
Unit of Measure: seconds
-22.75  (41.60) -50.33  (48.95) -6.40  (7.37) -53.80  (54.15)
8.Secondary Outcome
Title Boston Naming Test (BNT) Change From Baseline at Day 90
Hide Description 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.
Time Frame Baseline and Day 90
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 14 12 10 13
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.93  (3.10) 4.17  (4.11) 0.20  (2.74) 3.69  (3.82)
9.Secondary Outcome
Title Line Cancellation Test Change From Baseline at Day 90
Hide Description 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.
Time Frame Baseline and Day 90
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 7 10 10 9
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.03  (0.03) -0.07  (0.11) -0.04  (0.10) -0.00  (0.16)
10.Secondary Outcome
Title Trails A Test Change From Baseline at Day 90
Hide Description 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…)
Time Frame Baseline and Day 90
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 6 9 7 9
Mean (Standard Deviation)
Unit of Measure: seconds
-11.33  (22.20) -21.89  (22.10) -13.29  (21.91) -23.44  (25.53)
11.Secondary Outcome
Title Trails B Test Change From Baseline at Day 90
Hide Description 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)
Time Frame Baseline and Day 90
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 6 6 7 9
Mean (Standard Deviation)
Unit of Measure: seconds
-44.33  (51.60) -41.33  (62.89) -55.14  (59.92) -22.78  (71.22)
12.Secondary Outcome
Title Geriatric Depression Scale at Day 90
Hide Description 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.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description

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.
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description:
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
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
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
saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Overall Number of Participants Analyzed 20 17 18 19
Mean (Standard Deviation)
Unit of Measure: scores on a scale
7.25  (4.24) 3.88  (3.08) 3.56  (2.77) 4.74  (3.90)
Time Frame Adverse events were captured from the time of first dose to Day 30. Serious adverse events were captured from the time of first dose to Day 90.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Hide Arm/Group Description 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 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 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 saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
All-Cause Mortality
NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/24 (8.33%)      4/24 (16.67%)      3/24 (12.50%)      2/24 (8.33%)    
Cardiac disorders         
Cardiac Arrest †  1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Cardio-Respiratory Arrest †  0/24 (0.00%)  0 1/24 (4.17%)  1 2/24 (8.33%)  2 0/24 (0.00%)  0
Ventricular Fibrillation †  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1
Gastrointestinal disorders         
Gastrointestinal Hemorrhage †  0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
General disorders         
Sudden Cardiac Death †  0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders         
Cerebral Vascular Accident †  1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Hemorrhagic Transformation Stroke †  0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Ischemic Stroke †  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnoea †  0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NTx®-265 Low Dose NTx®-265 Medium Dose NTx®-265 High Dose Saline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/24 (37.50%)      19/24 (79.17%)      2/24 (8.33%)      10/24 (41.67%)    
Gastrointestinal disorders         
Nausea †  0/24 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0
Vomitting †  3/24 (12.50%)  3 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
General disorders         
Pain †  0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Pyrexia †  4/24 (16.67%)  4 6/24 (25.00%)  6 0/24 (0.00%)  0 3/24 (12.50%)  3
Infections and infestations         
Urinary Tract Infection †  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2
Musculoskeletal and connective tissue disorders         
Musculoskeletal Pain †  0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 2/24 (8.33%)  2
Nervous system disorders         
Headache †  0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Psychiatric disorders         
Depression †  0/24 (0.00%)  0 3/24 (12.50%)  3 0/24 (0.00%)  0 0/24 (0.00%)  0
Insomnia †  2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0 3/24 (12.50%)  3
Renal and urinary disorders         
Haematuria †  0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
†
Indicates events were collected by systematic assessment
The trial was terminated after 96 of a planned 128 patients were enrolled, thus limiting opportunities to demonstrate a clear statistical benefit of active therapy compared to placebo.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Chief Scientific Officer
Organization: Stem Cell Therapeutics Corp.
Phone: 403.245.5495 ext 226
EMail: adavidoff@stemcellthera.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stem Cell Therapeutics Corp.
ClinicalTrials.gov Identifier: NCT00938314    
Other Study ID Numbers: NTx®-265-CP-202-IS
First Submitted: July 9, 2009
First Posted: July 13, 2009
Results First Submitted: September 1, 2011
Results First Posted: November 9, 2011
Last Update Posted: November 29, 2011