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

Stroke Clinical Trial

— REGENESIS-LED  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00938314
• Other study ID #: NTx®-265-CP-202-IS
• Status: Terminated
• Phase: Phase 2
• First received: July 9, 2009
• Last updated: November 24, 2011
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2011
• Source: Stem Cell Therapeutics Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Canada	Foothills Medical Center , University of Calgary	Calgary	Alberta
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	Montreal Neurological Institute	Montreal	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
India	J.S.S Medical College & Hospital	Bangalore	Karnataka
India	M S Ramaiah Memorial Hospital	Bangalore	Karnataka
India	Vijaya Health Center	Chennai	Tamilnadu
India	Lalitha Super Specialty Hospitals Pvt.Ltd	Guntur	Andhra Pradesh
India	Apollo Hospitals	Hyderabad	Andhra Pradesh
India	Care Hospital	Hyderabad	Andhra Pradesh
India	Kamineni Hospital	Hyderabad	Andhra Pradesh
India	Krishna Institute of Medical Sciences	Hyderabad	Andhra Pradesh
India	Mediciti Hospital	Hyderabad	Andhra Pradesh
India	Owaisi Hospital and Research Centre	Hyderabad	Andhra Pradesh
India	St.Theresa's General Hospital	Hyderabad	Andhra Pradesh
India	Christian Medical College and Hospital	Ludhiana	Punjab
India	Max Super Speciality Hospital	New Delhi	Delhi
India	Ananthapuri Hospitals and Research Institute	Thiruvananthapuram	Kerala
India	DBR & SK Super Speciality Hospital	Tirupati	Andhra Pradesh
India	Christian Medical College Hospital	Vellore	Tamilnadu
India	Latha Superspecialities Hospital	Vijayawada	Andhra Pradesh
India	Suraksha Neuro Centre	Vijayawada	Andhra Pradesh
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Stem Cell Therapeutics Corp.

Countries where clinical trial is conducted

United States,  Canada,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline and Day 90	No
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.	Baseline and Day 90	No
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).	Baseline and Day 30	No
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.	Day 90	No
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.	Day 90	No
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.	Baseline and Day 90	No
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.	Baseline and Day 90	No
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.	Baseline and Day 90	No
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.	Baseline and Day 90	No
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…)	Baseline and Day 90	No
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)	Baseline and Day 90	No
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.	Day 90	No