Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)
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| ClinicalTrials.gov Identifier: NCT00938314 |
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Recruitment Status :
Terminated
(Slow Enrollment)
First Posted : July 13, 2009
Results First Posted : November 9, 2011
Last Update Posted : November 29, 2011
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Sponsor:
Stem Cell Therapeutics Corp.
Information provided by (Responsible Party):
Stem Cell Therapeutics Corp.
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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 and tolerability of NTx®-265 when given to acute ischemic stroke patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) Drug: Saline Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 96 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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) |
| Study Start Date : | August 2009 |
| Actual Primary Completion Date : | April 2010 |
| Actual Study Completion Date : | April 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Ischemic Stroke
| Arm | Intervention/treatment |
|---|---|
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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
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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:
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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
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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:
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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
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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:
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| 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% |
Primary Outcome Measures :
- National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90 [ Time Frame: Baseline and 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).
Secondary Outcome Measures :
- NIHSS Response >=4 at Day 90 [ Time Frame: Baseline and 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.
- NIHSS Change From Baseline at Day 30 [ Time Frame: Baseline and 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).
- Modified Rankin Scale (mRS) Response <=2 at Day 90 [ Time Frame: 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.
- Barthel Index at Day 90 [ Time Frame: 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.
- Action Research Arm Test (ARAT) Change From Baseline at Day 90 [ Time Frame: Baseline and 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.
- Gait Velocity Test Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ]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 ]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 ]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 ]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 ]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 ]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.
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938314
Locations
Show 23 study locations
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stem Cell Therapeutics Corp. |
| ClinicalTrials.gov Identifier: | NCT00938314 |
| Other Study ID Numbers: |
NTx®-265-CP-202-IS |
| First Posted: | July 13, 2009 Key Record Dates |
| Results First Posted: | November 9, 2011 |
| Last Update Posted: | November 29, 2011 |
| Last Verified: | November 2011 |
Additional relevant MeSH terms:
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Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Epoetin Alfa Chorionic Gonadotropin Hematinics Reproductive Control Agents Physiological Effects of Drugs |