Trial Outcomes & Findings for Beta-hCG + Erythropoietin in Acute Stroke (NCT NCT00362414)

NCT ID: NCT00362414

Last Updated: 2016-08-29

Results Overview

Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 3 mo
• Results posted on: 2016-08-29

Participant Flow

Subjects were consented and enrolled from September 2006 to February 2008 in accordance with local Institutional Review Boards at 3 North American sites: University of California Irvine Medical Center (n=11), Hoag Memorial Hospital Presbyterian (n=1), and the Foothills Hospital at University of Calgary (n=3).

Participant milestones

Measure	Beta-hCG + Erythropoietin Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Beta-hCG + Erythropoietin Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
Overall Study Death	2
Overall Study Adverse Event	1

Baseline Characteristics

Beta-hCG + Erythropoietin in Acute Stroke

Baseline characteristics by cohort

Measure	Beta-hCG + Erythropoietin n=15 Participants Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
Age, Continuous	72 years n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	12 participants n=93 Participants
Region of Enrollment Canada	3 participants n=93 Participants
History of Hypertension Yes	12 participants n=93 Participants
History of Hypertension No	3 participants n=93 Participants
History of Hyperlipidemia Yes	9 participants n=93 Participants
History of Hyperlipidemia No	6 participants n=93 Participants
History of Diabetes Mellitus Yes	6 participants n=93 Participants
History of Diabetes Mellitus No	9 participants n=93 Participants
History of Prior Stroke Yes	5 participants n=93 Participants
History of Prior Stroke No	10 participants n=93 Participants
History of Atrial Fibrillation Yes	4 participants n=93 Participants
History of Atrial Fibrillation No	11 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 mo

Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.

Outcome measures

Measure	Dual Growth Factor n=15 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Safety	0 participants

PRIMARY outcome

Timeframe: 3 mo

attributable to experimental intervention

Outcome measures

Measure	Dual Growth Factor n=15 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Morbidity	0 participants

PRIMARY outcome

Timeframe: 3 mo

attributable to experimental intervention

Outcome measures

Measure	Dual Growth Factor n=15 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Mortality	0 participants

SECONDARY outcome

Timeframe: 3 mo

Population: This number (9) is the total # subjects who could complete the test at all study time points; some subjects were unable to complete this test at one of the time points, especially the acute stroke assessment.

The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Total scores range from 0-57 points, a higher score being better with 57 being considered "normal".

Outcome measures

Measure	Dual Growth Factor n=9 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Action Research Arm Test	23 Units on a scale Interval 0.0 to 57.0

SECONDARY outcome

Timeframe: 3 mo

Fugl-Meyer arm scale is a measurement scale of the upper body with three sections being Proximal, Wrist/Hand, and Coordination/Speed. The scores can range from 0-66 with a higher score being better. A score of 66 is considered "normal" with no impairments.

Outcome measures

Measure	Dual Growth Factor n=12 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Fugl-Meyer Arm Scale	32 Units on a scale Interval 2.0 to 65.0

SECONDARY outcome

Timeframe: 3 mo.

Measure of leg motor impairment with three subsections which are Proximal, Hip/Knee, and Speed/Coordination. The scale ranges from 0-34 with a higher score being better. A score of 34 is considered "normal".

Outcome measures

Measure	Dual Growth Factor n=10 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Fugl-Meyer Leg Scale	20 Units on a scale Interval 3.0 to 34.0

SECONDARY outcome

Timeframe: 3 mo

Measure of aphasia or other language disturbance caused by stroke or other dementing disorders. It consists of 60 line drawings graded in difficulty in which patients are to name each picture.

Outcome measures

Measure	Dual Growth Factor n=13 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Boston Naming Test	2 Units on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 3 mo

Measure of spatial neglect where patients must cross out lines placed in a random orientation. Missed lines may indicate areas of spatial neglect.

Outcome measures

Measure	Dual Growth Factor n=8 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Line Cancellation Test	96 ratio of canceled lines on each side Interval 20.0 to 100.0

SECONDARY outcome

Timeframe: 3 mo

Measure of global impairment post stroke. It includes 11 items to examine levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scoring scale is between 0-42 where a higher score is indicative of a more severe stroke.

Outcome measures

Measure	Dual Growth Factor n=15 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
NIH Stroke Scale	10 Units on a scale Interval 6.0 to 19.0

SECONDARY outcome

Timeframe: 3 mo

Measure of depression done as a self-report. It is a series of 15 questions designed to be a screen for depression. The scores range from 0-15 with a higher score being more indicative of depression.

Outcome measures

Measure	Dual Growth Factor n=12 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Geriatric Depression Scale Short Form	5 Units on a scale Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: 3 mo

Measure of disability in terms of performance of activities of daily living (ADL). The scores range from 0-100 with a higher score being associated with a higher level of independence.

Outcome measures

Measure	Dual Growth Factor n=11 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Barthel Index	25 Units on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 3 mo

Measurement of infarct volume and percent change from baseline to Day 90.

Outcome measures

Measure	Dual Growth Factor n=7 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Infarct Volume Using Anatomical MRI	-22 percent change Standard Error 34

SECONDARY outcome

Timeframe: 3 mo

Measure of memory and executive function where one is asked to connect dots consecutively based on the number of the dot. Test taker is allowed 2 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.

Outcome measures

Measure	Dual Growth Factor n=7 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Trail Making A Test	8 correct connections Interval 0.0 to 25.0

SECONDARY outcome

Timeframe: 3 mo.

Measure of memory and executive function where one is asked to connect dots with letters and numbers alternating between number and letter and connecting dots consecutively. Test taker is allowed 4 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.

Outcome measures

Measure	Dual Growth Factor n=5 Participants All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Trail Making B Test	3 correct connections Interval 0.0 to 11.0

Adverse Events

Beta-hCG + Erythropoietin

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Beta-hCG + Erythropoietin n=15 participants at risk Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
General disorders Death	13.3% 2/15 • Number of events 2
Vascular disorders Deep Vein Thrombosis	13.3% 2/15 • Number of events 2
Nervous system disorders Cerebral embolism	6.7% 1/15 • Number of events 2
Infections and infestations Mediastinal sepsis	6.7% 1/15 • Number of events 1
General disorders Retroperitoneal hemorrhage	6.7% 1/15 • Number of events 1
Cardiac disorders Cardiac arrest	6.7% 1/15 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Steven Cramer

University of California Irvine

Phone: (714) 456-6876

Email: scramer@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place