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Beta-hCG + Erythropoietin in Acute Stroke (BETAS)

This study has been completed.
Sponsor:
Collaborators:
Stem Cell Therapeutics Corp.
Hoag Memorial Hospital Presbyterian
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00362414
First received: August 9, 2006
Last updated: August 16, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke.

Condition Intervention Phase
Acute Stroke
Drug: Dual Growth Factor
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Beta-hCG + Erythropoietin in Acute Stroke

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Safety [ Time Frame: 3 mo ] [ Designated as safety issue: Yes ]
    Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.

  • Morbidity [ Time Frame: 3 mo ] [ Designated as safety issue: Yes ]
    attributable to experimental intervention

  • Mortality [ Time Frame: 3 mo ] [ Designated as safety issue: Yes ]
    attributable to experimental intervention


Secondary Outcome Measures:
  • Action Research Arm Test [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Total scores range from 0-57 points, a higher score being better with 57 being considered "normal".

  • Fugl-Meyer Arm Scale [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    Fugl-Meyer arm scale is a measurement scale of the upper body with three sections being Proximal, Wrist/Hand, and Coordination/Speed. The scores can range from 0-66 with a higher score being better. A score of 66 is considered "normal" with no impairments.

  • Fugl-Meyer Leg Scale [ Time Frame: 3 mo. ] [ Designated as safety issue: No ]
    Measure of leg motor impairment with three subsections which are Proximal, Hip/Knee, and Speed/Coordination. The scale ranges from 0-34 with a higher score being better. A score of 34 is considered "normal".

  • Boston Naming Test [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    Measure of aphasia or other language disturbance caused by stroke or other dementing disorders. It consists of 60 line drawings graded in difficulty in which patients are to name each picture.

  • Line Cancellation Test [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    Measure of spatial neglect where patients must cross out lines placed in a random orientation. Missed lines may indicate areas of spatial neglect.

  • NIH Stroke Scale [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    Measure of global impairment post stroke. It includes 11 items to examine levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scoring scale is between 0-42 where a higher score is indicative of a more severe stroke.

  • Geriatric Depression Scale Short Form [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    Measure of depression done as a self-report. It is a series of 15 questions designed to be a screen for depression. The scores range from 0-15 with a higher score being more indicative of depression.

  • Barthel Index [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    Measure of disability in terms of performance of activities of daily living (ADL). The scores range from 0-100 with a higher score being associated with a higher level of independence.

  • Infarct Volume Using Anatomical MRI [ Time Frame: 3 mo ] [ Designated as safety issue: Yes ]
    Measurement of infarct volume and percent change from baseline to Day 90.

  • Trail Making A Test [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    Measure of memory and executive function where one is asked to connect dots consecutively based on the number of the dot. Test taker is allowed 2 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.

  • Trail Making B Test [ Time Frame: 3 mo. ] [ Designated as safety issue: No ]
    Measure of memory and executive function where one is asked to connect dots with letters and numbers alternating between number and letter and connecting dots consecutively. Test taker is allowed 4 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.


Enrollment: 15
Study Start Date: August 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dual Growth Factor
All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.
Drug: Dual Growth Factor

10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation

30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation


Detailed Description:
Patients with a new stroke will be evaluated at the University of California Irvine Medical Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian. Standard stroke pathways will be used to identify such patients and to initiate standard of care therapy. Patients potentially eligible for study enrollment will be identified, screened, then consented and enrolled. Those meeting all entry criteria, and no exclusion criteria, will undergo additional baseline testing including brain MRI. A 9-day course of B-E therapy will then begin, always within 48 hours after stroke onset. This therapy will consist of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of study participation), followed by a one day washout period (day 6), followed by Epo (three once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation). Patients will be examined at several time points during therapy, as well as 6 weeks and 3 months after stroke onset. The primary outcome measures are related to safety, while secondary outcome measures are related to disability, neurological status, and MRI measures.
  Eligibility

Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 21-85
  2. NIHSS score 6-24 at time of enrollment, ensuring that stroke is neither mild nor devastating
  3. Stroke is ischemic in origin, supratentorial, and radiologically confirmed
  4. Patient is 24-48 hours from time of stroke onset at time that first dose of B-E therapy is administered. Time of onset is when symptoms began, and stroke occurred during sleep, time of onset is when patient was last seen to be normal.
  5. Reasonable expectation of availability to receive the full 9 day B-E therapy course
  6. Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated

Exclusion Criteria:

  1. Pre-existing and active major psychiatric or other neurological disease
  2. History of significant alcohol or drug abuse in the prior 3 years
  3. Serum hemoglobin > 16 g/dL in a male patient or > 14 g/dL in a female patient; or a platelet count > 400,000/mm3 in either a male or female patient
  4. Advanced liver, kidney, cardiac, or pulmonary disease; the former will be operationally defined as a serum bilirubin > 4 mg/dL, alkaline phosphatase > 250 U/L, SGOT > 150 U/L, SGPT >150 U/L, or creatinine > 3.5 mg/dL
  5. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years, using a test that reliably detects beta-hCG levels > 25 with normal levels being < 8 IU/L.
  6. Contraindication to study participation on the basis of any of the following:

    1. Allergy or other contraindication to initiating either beta-hCG or Erythropoietin
    2. Known hypersensitivity to mammalian cell-derived products or hypersensitivity to albumin
    3. A known diagnosis of prostatic cancer; note that prostate specific antigen will be collected for retrospective assessment of safety, but will not be used to ascertain study eligibility
    4. Dysuria of unexplained origin
    5. Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 diastolic despite antihypertensive therapy
  7. Current use of either beta-hCG or Erythropoietin
  8. Other condition known to elevate beta-hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor
  9. Terminal medical diagnosis consistent with survival < 1 year
  10. Known hypercoagulable state, which for the purposes of this study will deficiency of proteins C, S, or antithrombin III; activated protein C resistance; prothrombin gene mutation; or an anti-phospholipid antibody syndrome as based on clinical and laboratory measures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362414

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868-4280
Sponsors and Collaborators
University of California, Irvine
Stem Cell Therapeutics Corp.
Hoag Memorial Hospital Presbyterian
Investigators
Principal Investigator: Steven C. Cramer, MD, MMSc University of California, Irvine
  More Information

Responsible Party: Steven C. Cramer, MD, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00362414     History of Changes
Other Study ID Numbers: HS#2005-4800 
Study First Received: August 9, 2006
Results First Received: June 12, 2012
Last Updated: August 16, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mitogens
Epoetin Alfa
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hematinics

ClinicalTrials.gov processed this record on September 29, 2016