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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

human chorionic gonadotropin (hCG), then epoetin alfa (EPO)

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

human chorionic gonadotropin (hCG), then epoetin alfa (EPO)

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

human chorionic gonadotropin (hCG), then epoetin alfa (EPO)

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Saline Placebo

Intervention Type DRUG

Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Ovidrel Ovitrelle Epogen Eprex Ovidrel Ovitrelle Epogen Eprex Ovidrel Ovitrelle Epogen Eprex Sodium Chloride 0.9%

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven C Cramer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of California, Irvine Medical Center

Michael D Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Neurosciences, University of Calgary

Locations

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University of California, Irvine Medical Center

Orange, California, United States

Site Status

Foothills Medical Center , University of Calgary

Calgary, Alberta, Canada

Site Status

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Montreal Neurological Institute

Montreal, Quebec, Canada

Site Status