Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 419 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00938314
Recruitment Status : Terminated (Slow Enrollment)
First Posted : July 13, 2009
Results First Posted : November 9, 2011
Last Update Posted : November 29, 2011
Sponsor:
Information provided by (Responsible Party):
Stem Cell Therapeutics Corp.

Tracking Information
First Submitted Date  ICMJE July 9, 2009
First Posted Date  ICMJE July 13, 2009
Results First Submitted Date  ICMJE September 1, 2011
Results First Posted Date  ICMJE November 9, 2011
Last Update Posted Date November 29, 2011
Study Start Date  ICMJE August 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2011)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2009)
  • Modified Rankin Score [ Time Frame: Day 90 ]
  • NIHSS response [ Time Frame: Day 90 ]
  • Adverse events [ Time Frame: Day 90 ]
Change History Complete list of historical versions of study NCT00938314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2009)
  • Barthel index [ Time Frame: Day 90 ]
  • Action Research Arm Test [ Time Frame: Day 90 ]
  • Gait Velocity Test [ Time Frame: Day 90 ]
  • Boston Naming Test [ Time Frame: Day 90 ]
  • Line Cancellation Test [ Time Frame: Day 90 ]
  • Trails A & B Test [ Time Frame: Day 90 ]
  • Geriatric Depression Scale [ Time Frame: Day 90 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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:
    • Ovidrel
    • Ovitrelle
    • Epogen
    • Eprex
  • 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:
    • Ovidrel
    • Ovitrelle
    • Epogen
    • Eprex
  • 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:
    • Ovidrel
    • Ovitrelle
    • Epogen
    • Eprex
  • 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%
Study Arms  ICMJE
  • 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
    Intervention: Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
  • 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
    Intervention: Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
  • 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
    Intervention: Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
  • Placebo Comparator: Saline Placebo
    Intervention: Drug: Saline Placebo
Publications * Cramer SC, Hill MD; REGENESIS-LED Investigators. Human choriogonadotropin and epoetin alfa in acute ischemic stroke patients (REGENESIS-LED trial). Int J Stroke. 2014 Apr;9(3):321-7. doi: 10.1111/ijs.12260. Epub 2014 Mar 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 24, 2011)
96
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2009)
128
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00938314
Other Study ID Numbers  ICMJE NTx®-265-CP-202-IS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stem Cell Therapeutics Corp.
Study Sponsor  ICMJE Stem Cell Therapeutics Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Stem Cell Therapeutics Corp.
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP