Clinical trial NCT00938314: Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke
Lead sponsor: Stem Cell Therapeutics Corp.
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90
timeFrame: Baseline and Day 90
Secondary outcomes:
measure: NIHSS Response >=4 at Day 90
timeFrame: Baseline and Day 90
measure: NIHSS Change From Baseline at Day 30
timeFrame: Baseline and Day 30
measure: Modified Rankin Scale (mRS) Response <=2 at Day 90
timeFrame: Day 90
measure: Barthel Index at Day 90
timeFrame: Day 90
measure: Action Research Arm Test (ARAT) Change From Baseline at Day 90
timeFrame: Baseline and Day 90
measure: Gait Velocity Test Change From Baseline at Day 90
timeFrame: Baseline and Day 90
measure: Boston Naming Test (BNT) Change From Baseline at Day 90
timeFrame: Baseline and Day 90
measure: Line Cancellation Test Change From Baseline at Day 90
timeFrame: Baseline and Day 90
measure: Trails A Test Change From Baseline at Day 90
timeFrame: Baseline and Day 90
measure: Trails B Test Change From Baseline at Day 90
timeFrame: Baseline and Day 90
measure: Geriatric Depression Scale at Day 90
timeFrame: Day 90
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Calgary
country: Canada
facility: Foothills Medical Center , University of Calgary
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
city: Guntur
country: India
facility: Lalitha Super Specialty Hospitals Pvt.Ltd
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Care Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Krishna Institute of Medical Sciences
state: Andhra Pradesh
city: Hyderabad
country: India
facility: St.Theresa's General Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Apollo Hospitals
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Owaisi Hospital and Research Centre
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Mediciti Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Kamineni Hospital
state: Andhra Pradesh
city: Tirupati
country: India
facility: DBR & SK Super Speciality Hospital
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Latha Superspecialities Hospital
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Suraksha Neuro Centre
state: Andhra Pradesh
city: New Delhi
country: India
facility: Max Super Speciality Hospital
state: Delhi
city: Bangalore
country: India
facility: M S Ramaiah Memorial Hospital
state: Karnataka
city: Bangalore
country: India
facility: J.S.S Medical College & Hospital
state: Karnataka
city: Thiruvananthapuram
country: India
facility: Ananthapuri Hospitals and Research Institute
state: Kerala
city: Ludhiana
country: India
facility: Christian Medical College and Hospital
state: Punjab
city: Chennai
country: India
facility: Vijaya Health Center
state: Tamilnadu
city: Vellore
country: India
facility: Christian Medical College Hospital
state: Tamilnadu
Study officials:
affiliation: Department of Neurology, University of California, Irvine Medical Center
name: Steven C Cramer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Neurosciences, University of Calgary
name: Michael D Hill, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.