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

NCT00663416 | Terminated Phase 2 DMC

• 1 other identifier: NTx™-265-CP-201-IS (CA)
• Study Type: interventional
• Target: 134
• Locations: 2 countries
• Sites: 26

Brief Summary

Primary objective: To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control. Secondary objective: To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Modified Rankin Score (mRS)

  Day 90

• NIHSS response

  Day 90

Secondary Outcomes (8)

• NIHSS

  Day 90

• mRS

  Day 90

• Barthel Index

  Day 90

• Action Research Arm Test

  Day 90

• Gait Velocity Test

  Day 90

Study Arms (2)

1

EXPERIMENTAL

Drug: NTx™-265: rhCG, then rEPO

2

PLACEBO COMPARATOR

Drug: Saline placebo

Interventions

NTx™-265: rhCG, then rEPO DRUG

* rhCG 10,000 IU, SC, on Day 1, 3, and 5 of study participation, then * rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation

Also known as: Ovidrel, Eprex

1

Saline placebo DRUG

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

Also known as: Sodium Chloride 0.9%

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85.
• NIHSS score 6-24 within 24-48 hours after stroke onset and enrolment.
• Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment.
• Patient is 24-48 hours from time of stroke onset when the first dose of NTxTM-265 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self-reported to be normal.
• Reasonable expectation of availability to receive the full 9 day NTxTM-265 course of therapy, and to be available for subsequent follow-up visits.
• Reasonable expectation that patient will receive standard post-stroke physical, occupational and speech therapy as indicated.
• Female patient is either:
• Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy) or
• If of childbearing potential, agrees to use two of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits:
• Condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (e.g., implants, injectables, combined oral, etc) OR
• A vasectomised partner OR
• Abstinence

You may not qualify if:

• Patients presenting with lacunar, hemorrhagic and/or brain stem stroke.
• Patients who have received thrombolytic treatment with tPA following the index stroke.
• Patients classified as comatose, defined as a patient who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS 1A score must be \<2)
• Women who have tested positive for pregnancy, or are breast-feeding or are not using a highly effective method of birth control that can be maintained for the duration of the study.
• Serum hemoglobin \> 16 g/dL (males) or \> 14 g/dL (females); or platelet count \> 400,000/mm3.
• Advanced liver,kidney, cardiac or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher)
• Serum bilirubin \> 1.5 x upper limit of normal (ULN).
• Alkaline phosphatase \> 2.5 x ULN.
• AST\>2.5xULN.
• ALT \> 2.5 x ULN.
• Creatinine \> 2.0 x ULN.
• Patients with known and documented transferrin saturation \< 20%.
• Patients with known and documented ferritin \< 100 ng/mL.
• Patients with known and documented elevated PSA levels, or a PSA level of ≥ 4 ng/mL at screening.
• Patients with a known or current history of abnormal hypercoagulability parameters , including known cardiolipin/antiphospholipid antibody syndrome.

Sponsors & Collaborators

• Stem Cell Therapeutics Corp.: lead

Study Sites (26)

Department of Clinical Neurosciences, Univeristy of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Walter Mackenzie Health Sciences Centre

Edmonton, Alberta, T6G 2B7, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X3, Canada

Location

Chinook Regional Hospital

Lethbridge, Alberta, T1J 1W5, Canada

Location

Penticton Regional Hospital

Penticton, British Columbia, V2A 3G6, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Vancouver Island Health Research Centre

Victoria, British Columbia, V8R 1J8, Canada

Location

Brandon Regional Health Centre

Brandon, Manitoba, R7A 2B3, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

McMaster Clinic

Hamilton, Ontario, L8L 2X2, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Division of Neurology , Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Department of Neurology, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Montreal Neurological Institute

Montreal, Quebec, H3A 2B4, Canada

Location

Department of Neurology, Care Hospital

Hyderabad, Andhra Pradesh, 500001, India

Location

Krishna Institute of Medical Sciences

Hyderabad, Andhra Pradesh, 500003, India

Location

Department of Neurology, Apollo Hospitals

Hyderabad, Andhra Pradesh, 500033, India

Location

Department of Neurology, Nizam's Institute of Medical Science

Hyderabad, Andhra Pradesh, 500082, India

Location

M S Ramaiah Memorial Hospital

Bangalore, Karnataka, 560054, India

Location

Max Super Speciality Hospital

New Delhi, National Capital Territory of Delhi, 110017, India

Location

Christian Medical College & Hospital

Ludhiana, Punjab, 141008, India

Location

Department of Neurology, Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

AMRI Hospital

Kolkata, West Bengal, 700029, India

Location

Department of Neurology, B.P.Poddar Hospital & Medical Research Ltd

Kolkata, West Bengal, 700053, India

Location

MeSH Terms

Conditions

Stroke

Interventions

Ovidrel; Epoetin Alfa; Sodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael D Hill, MD

  Department of Clinical Neurosciences, University of Calgary

  PRINCIPAL INVESTIGATOR

• Steven C Cramer, MD

  Department of Neurology, University of Califonia, Irvine Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: January 1, 2009
• Last Updated: August 12, 2009

Record last verified: 2009-08

Locations

IN (10); CA (16)