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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00938314

Run by

Stem Cell Therapeutics Corp.

People needed

96

Starts

2009-08-01

Expected to finish

2010-04-01

Last updated by the study team

2011-11-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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