AzTrials
AzTrials

StrokePhase 2REGENESIS-LEDNCT00938314

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

A Phase 2 study testing human chorionic gonadotropin (hCG), then epoetin alfa (EPO) in people with Stroke, run by Stem Cell Therapeutics Corp. at 23 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
23 sitesin 3 countries
Study dates
Aug 2009to Apr 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

23 sites in 3 countries.

23 sites in 3 countries

India18 sites

  • M S Ramaiah Memorial Hospital

    Bangalore, Karnataka, 560054

  • J.S.S Medical College & Hospital

    Bangalore, Karnataka, 570004

  • Vijaya Health Center

    Chennai, Tamil Nadu, 600026

  • Lalitha Super Specialty Hospitals Pvt.Ltd

    Guntur, Andhra Pradesh, 522001

  • Care Hospital

    Hyderabad, Andhra Pradesh, 500001

  • Krishna Institute of Medical Sciences

    Hyderabad, Andhra Pradesh, 500003

  • St.Theresa's General Hospital

    Hyderabad, Andhra Pradesh, 500018

  • Apollo Hospitals

    Hyderabad, Andhra Pradesh, 500023

  • Owaisi Hospital and Research Centre

    Hyderabad, Andhra Pradesh, 500059

  • Mediciti Hospital

    Hyderabad, Andhra Pradesh, 500063

  • Kamineni Hospital

    Hyderabad, Andhra Pradesh, 500068

  • Christian Medical College and Hospital

    Ludhiana, Punjab, 141008

  • Max Super Speciality Hospital

    New Delhi, National Capital Territory of Delhi, 110017

  • Ananthapuri Hospitals and Research Institute

    Thiruvananthapuram, Kerala, 695024

  • DBR & SK Super Speciality Hospital

    Tirupati, Andhra Pradesh, 517501

  • Christian Medical College Hospital

    Vellore, Tamil Nadu, 632004

  • Latha Superspecialities Hospital

    Vijayawada, Andhra Pradesh, 520002

  • Suraksha Neuro Centre

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

Canada4 sites

  • Foothills Medical Center , University of Calgary

    Calgary, Alberta, T2N 2T9

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 3A7

  • Montreal Neurological Institute

    Montreal, Quebec, H3A 2B4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

United States1 site

  • University of California, Irvine Medical Center

    Orange, California, 92868

Other trials in United States

About this study

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)

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.
Conditions
Stroke
Being tested
human chorionic gonadotropin (hCG), then epoetin alfa (EPO), Saline Placebo
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Ovidrel, Ovitrelle, Epogen, Eprex

    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

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

    Also called Ovidrel, Ovitrelle, Epogen, Eprex

    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

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

    Also called Ovidrel, Ovitrelle, Epogen, Eprex

    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 PlaceboDrug

    Also called Sodium Chloride 0.9%

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

Study groups in NCT00938314
Study groupRoleWhat they receive
NTx®-265 Low DoseExperimentalhCG 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
Receives: Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
NTx®-265 Medium DoseExperimentalhCG 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
Receives: Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
NTx®-265 High DoseExperimentalhCG 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
Receives: Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
Saline PlaceboPlacebo comparatorNot described
Receives: Drug: Saline Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at 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).

    Measured: Baseline and Day 90

Secondary outcomes (11)

  1. NIHSS Response >=4 at 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.

    Measured: Baseline and Day 90

  2. NIHSS Change From Baseline at 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).

    Measured: Baseline and Day 30

  3. Modified Rankin Scale (mRS) Response <=2 at 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.

    Measured: Day 90

  4. Barthel Index at 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.

    Measured: Day 90

  5. Action Research Arm Test (ARAT) Change From Baseline at 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.

    Measured: Baseline and Day 90

  6. Gait Velocity Test Change From Baseline at Day 90

    The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.

    Measured: Baseline and Day 90

  7. Boston Naming Test (BNT) Change From Baseline at 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.

    Measured: Baseline and Day 90

  8. Line Cancellation Test Change From Baseline at 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.

    Measured: Baseline and Day 90

  9. Trails A Test Change From Baseline at 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…)

    Measured: Baseline and Day 90

  10. Trails B Test Change From Baseline at 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)

    Measured: Baseline and Day 90

  11. Geriatric Depression Scale at 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.

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionApr 2010
  4. Study completionApr 2010

Why it stopped: Slow Enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00938314
Sponsor's protocol ID
NTx®-265-CP-202-IS
Acronym
REGENESIS-LED
Status last verified
Nov 2011
First submitted
9 Jul 2009
Last updated
29 Nov 2011
Data monitoring committee
Yes

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.

    PubMed 24588854

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing human chorionic gonadotropin (hCG), then epoetin alfa (EPO) in people with Stroke, run by Stem Cell Therapeutics Corp. at 23 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in India, Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90 (time frame: Baseline and Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00938314, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in