Status:
TERMINATED
Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
Lead Sponsor:
Stem Cell Therapeutics Corp.
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00938314
Start Date
August 1 2009
End Date
April 1 2010
Last Update
November 29 2011
Active Locations (23)
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1
University of California, Irvine Medical Center
Orange, California, United States, 92868
2
Foothills Medical Center , University of Calgary
Calgary, Alberta, Canada, T2N 2T9
3
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5