Trial · NCT00938314

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

NCT00938314, Phase 2, Terminated, Stem Cell Therapeutics Corp.; results first posted 2011-11-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients. Trials, record NCT00938314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00938314

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
NCT number: NCT00938314
Status: Terminated
Phases: Phase 2
Enrollment: 96 participants, actual
Lead sponsor: Stem Cell Therapeutics Corp.
Conditions: Stroke
Interventions: human chorionic gonadotropin (hCG), then epoetin alfa (EPO), human chorionic gonadotropin (hCG), then epoetin alfa (EPO), human chorionic gonadotropin (hCG), then epoetin alfa (EPO), Saline Placebo
First posted: 2009-07-13
Last updated: 2011-11-29
Results first posted: 2011-11-09
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90	Baseline and 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).
Secondary	NIHSS Response >=4 at Day 90	Baseline and 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.
Secondary	NIHSS Change From Baseline at Day 30	Baseline and 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).
Secondary	Modified Rankin Scale (mRS) Response <=2 at Day 90	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.
Secondary	Barthel Index at Day 90	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.
Secondary	Action Research Arm Test (ARAT) Change From Baseline at Day 90	Baseline and 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.
Secondary	Gait Velocity Test Change From Baseline at Day 90	Baseline and Day 90	The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.
Secondary	Boston Naming Test (BNT) Change From Baseline at Day 90	Baseline and 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.
Secondary	Line Cancellation Test Change From Baseline at Day 90	Baseline and 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.
Secondary	Trails A Test Change From Baseline at Day 90	Baseline and 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…)

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90	Baseline and 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.	scores on a scale	MEAN
SECONDARY	NIHSS Response >=4 at Day 90	Baseline and 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.	participants	NUMBER
SECONDARY	NIHSS Change From Baseline at Day 30	Baseline and Day 30	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.	scores on a scale	MEAN
SECONDARY	Modified Rankin Scale (mRS) Response <=2 at Day 90	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.	participants	NUMBER
SECONDARY	Barthel Index at Day 90	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.	Scores on a scale	MEAN
SECONDARY	Action Research Arm Test (ARAT) Change From Baseline at Day 90	Baseline and Day 90	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.	scores on a scale	MEAN
SECONDARY	Gait Velocity Test Change From Baseline at Day 90	Baseline and Day 90	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.	seconds	MEAN
SECONDARY	Boston Naming Test (BNT) Change From Baseline at Day 90	Baseline and Day 90	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.	Scores on a scale	MEAN
SECONDARY	Line Cancellation Test Change From Baseline at Day 90	Baseline and Day 90	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.	scores on a scale	MEAN
SECONDARY	Trails A Test Change From Baseline at Day 90	Baseline and Day 90	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.	seconds	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90	NTx®-265 Low Dose		6.79	Standard Deviation 4.22	scores on a scale
National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90	NTx®-265 Medium Dose		6.50	Standard Deviation 4.53	scores on a scale
National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90	NTx®-265 High Dose		6.08	Standard Deviation 3.30	scores on a scale
National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90	Saline Placebo		7.17	Standard Deviation 4.24	scores on a scale
NIHSS Response >=4 at Day 90	NTx®-265 Low Dose	No Response (<4)	6		participants
NIHSS Response >=4 at Day 90	NTx®-265 Medium Dose	No Response (<4)	7		participants
NIHSS Response >=4 at Day 90	NTx®-265 High Dose	No Response (<4)	5		participants
NIHSS Response >=4 at Day 90	Saline Placebo	No Response (<4)	5		participants
NIHSS Response >=4 at Day 90	NTx®-265 Low Dose	Response (>=4)	18		participants
NIHSS Response >=4 at Day 90	NTx®-265 Medium Dose	Response (>=4)	17		participants

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Cohort 1	STARTED	NTx®-265 Low Dose	24
Cohort 1	STARTED	NTx®-265 Medium Dose	0
Cohort 1	STARTED	NTx®-265 High Dose	0
Cohort 1	STARTED	Placebo	8
Cohort 1	COMPLETED	NTx®-265 Low Dose	22
Cohort 1	COMPLETED	NTx®-265 Medium Dose	0
Cohort 1	COMPLETED	NTx®-265 High Dose	0
Cohort 1	COMPLETED	Placebo	6
Cohort 1	NOT COMPLETED	NTx®-265 Low Dose	2
Cohort 1	NOT COMPLETED	NTx®-265 Medium Dose	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Depression	Psychiatric disorders	NTx®-265 Low Dose	0	24	0
other	Depression	Psychiatric disorders	NTx®-265 Medium Dose	3	24	3
other	Depression	Psychiatric disorders	NTx®-265 High Dose	0	24	0
other	Depression	Psychiatric disorders	Saline Placebo	0	24	0
other	Haematuria	Renal and urinary disorders	NTx®-265 Low Dose	0	24	0
other	Haematuria	Renal and urinary disorders	NTx®-265 Medium Dose	2	24	2
other	Haematuria	Renal and urinary disorders	NTx®-265 High Dose	0	24	0
other	Haematuria	Renal and urinary disorders	Saline Placebo	0	24	0
other	Headache	Nervous system disorders	NTx®-265 Low Dose	0	24	0
other	Headache	Nervous system disorders	NTx®-265 Medium Dose	2	24	2

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NTx®-265 Low Dose
Total, all-cause mortality	NTx®-265 Medium Dose
Total, all-cause mortality	NTx®-265 High Dose
Total, all-cause mortality	Saline Placebo
Total, other adverse events	NTx®-265 Low Dose	9	24
Total, other adverse events	NTx®-265 Medium Dose	19	24
Total, other adverse events	NTx®-265 High Dose	2	24
Total, other adverse events	Saline Placebo	10	24
Total, serious adverse events	NTx®-265 Low Dose	2	24
Total, serious adverse events	NTx®-265 Medium Dose	4	24

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24588854	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Cancellation Test	Secondary outcome	ConductCognition
Picture Naming Test	Secondary outcome	ConductCognition
Trail Making Test A	Secondary outcome	ConductCognition
Trail Making Test B	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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