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

Purpose

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.

Condition	Intervention	Phase
Stroke	Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) Drug: Saline Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled, Multicenter, Dose Escalation Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)

Resource links provided by NLM:

Drug Information available for: Chorionic Gonadotropin Erythropoietin Epoetin Alfa Choriogonadotropin Alfa

U.S. FDA Resources

Further study details as provided by Stem Cell Therapeutics Corp.:

Primary Outcome Measures:

National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
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 Outcome Measures:

NIHSS Response >=4 at Day 90 [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
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.
NIHSS Change From Baseline at Day 30 [ Time Frame: Baseline and Day 30 ] [ Designated as safety issue: No ]
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).
Modified Rankin Scale (mRS) Response <=2 at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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.
Barthel Index at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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.
Action Research Arm Test (ARAT) Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
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.
Gait Velocity Test Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.
Boston Naming Test (BNT) Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
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.
Line Cancellation Test Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
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.
Trails A Test Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
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…)
Trails B Test Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
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)
Geriatric Depression Scale at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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.

Enrollment:	96
Study Start Date:	August 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NTx®-265 Low Dose 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	Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) 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 Other Names: Ovidrel Ovitrelle Epogen Eprex
Experimental: 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	Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) 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 Other Names: Ovidrel Ovitrelle Epogen Eprex
Experimental: 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	Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) 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 Other Names: Ovidrel Ovitrelle Epogen Eprex
Placebo Comparator: Saline Placebo	Drug: 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 Other Name: Sodium Chloride 0.9%

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-85
NIHSS score 8-20
Stroke is ischemic in origin, supratentorial, and radiologically confirmed
Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered
Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits
Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
Female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study

Exclusion Criteria:

Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
Patients who have received tissue plasminogen activator (tPA)following the index stroke
Patients classified as comatose
Women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control
Serum hemoglobin > 16 grams(g)/deciliter (dL)(males) or > 14 g/dL (females); or platelet count > 400,000/cubic millimeters(mm3)
Advanced liver, kidney, cardiac, or pulmonary disease
Elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (AST) or alanine transaminase (ALT),creatinine, or prostate-specific antigen (PSA) levels
Patients with a known history of hypercoagulability
Expected survival < 1 year
Allergy or other contraindication to hCG or EPO
A known diagnosis of cancer in the previous 5 years
Uncontrolled hypertension
Use of either hCG or epoetin alfa within the previous 90 days
Any condition known to elevate hCG
Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS)≥ 2
Any patients not living independently
Any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial
With the exception of the qualifying stroke, any other stroke within the previous 3 months
Patients who cannot take anti-platelet or anti-coagulant therapy
Pre-existing and active major psychiatric or other chronic neurological disease
Alcohol abuse or have a history of substance abuse or dependency within 12 months prior to the study
Currently participating in another investigational study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938314

Locations

United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Canada, Alberta
Foothills Medical Center , University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal Neurological Institute
Montreal, Quebec, Canada, H3A 2B4
India
Lalitha Super Specialty Hospitals Pvt.Ltd
Guntur, Andhra Pradesh, India, 522001
Mediciti Hospital
Hyderabad, Andhra Pradesh, India, 500063
Krishna Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 500003
Care Hospital
Hyderabad, Andhra Pradesh, India, 500001
St.Theresa's General Hospital
Hyderabad, Andhra Pradesh, India, 500018
Apollo Hospitals
Hyderabad, Andhra Pradesh, India, 500023
Owaisi Hospital and Research Centre
Hyderabad, Andhra Pradesh, India, 500059
Kamineni Hospital
Hyderabad, Andhra Pradesh, India, 500068
DBR & SK Super Speciality Hospital
Tirupati, Andhra Pradesh, India, 517501
Latha Superspecialities Hospital
Vijayawada, Andhra Pradesh, India, 520002
Suraksha Neuro Centre
Vijayawada, Andhra Pradesh, India, 520002
Max Super Speciality Hospital
New Delhi, Delhi, India, 110017
M S Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
J.S.S Medical College & Hospital
Bangalore, Karnataka, India, 570004
Ananthapuri Hospitals and Research Institute
Thiruvananthapuram, Kerala, India, 695024
Christian Medical College and Hospital
Ludhiana, Punjab, India, 141008
Vijaya Health Center
Chennai, Tamilnadu, India, 600026
Christian Medical College Hospital
Vellore, Tamilnadu, India, 632004

Sponsors and Collaborators

Stem Cell Therapeutics Corp.

Investigators

Principal Investigator:	Steven C Cramer, MD	Department of Neurology, University of California, Irvine Medical Center
Principal Investigator:	Michael D Hill, MD	Department of Clinical Neurosciences, University of Calgary

More Information

No publications provided

Responsible Party:	Stem Cell Therapeutics Corp.
ClinicalTrials.gov Identifier:	NCT00938314 History of Changes
Other Study ID Numbers:	NTx®-265-CP-202-IS
Study First Received:	July 9, 2009
Results First Received:	September 1, 2011
Last Updated:	November 24, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada India: Drugs Controller General of India

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction

Brain Ischemia
Chorionic Gonadotropin
Epoetin Alfa
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on May 23, 2013

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