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Sponsored by: |
Stem Cell Therapeutics Corp. |
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Information provided by: | Stem Cell Therapeutics Corp. |
ClinicalTrials.gov Identifier: | NCT00663416 |
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.
Condition | Intervention | Phase |
---|---|---|
Stroke |
Drug: NTx™-265: rhCG, then rEPO Drug: Saline placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS) |
Estimated Enrollment: | 134 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: NTx™-265: rhCG, then rEPO
|
2: Placebo Comparator |
Drug: Saline placebo
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Female patient is either:
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:
Exclusion Criteria
Allergy or other contraindication to hCG including:
Allergy or other contraindication to epoetin alfa:
Canada, Alberta | |
Department of Clinical Neurosciences, Univeristy of Calgary | |
Calgary, Alberta, Canada, T2N 2T9 | |
Chinook Regional Hospital | |
Lethbridge, Alberta, Canada, T1J 1W5 | |
Walter Mackenzie Health Sciences Centre | |
Edmonton, Alberta, Canada, T6G 2B7 | |
Grey Nuns Community Hospital | |
Edmonton, Alberta, Canada, T6L 5X3 | |
Canada, British Columbia | |
Vancouver General Hospital | |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Vancouver Island Health Research Centre | |
Victoria, British Columbia, Canada, V8R 1J8 | |
Penticton Regional Hospital | |
penticton, British Columbia, Canada, V2A 3G6 | |
Canada, Manitoba | |
Brandon Regional Health Centre | |
Brandon, Manitoba, Canada, R7A 2B3 | |
Canada, Nova Scotia | |
Queen Elizabeth II Health Sciences Centre | |
Halifax, Nova Scotia, Canada, B3H 3A7 | |
Canada, Ontario | |
Trillium Health Centre | |
Mississauga, Ontario, Canada, L5B 1B8 | |
University Health Network | |
Toronto, Ontario, Canada, M5T 2S8 | |
Department of Neurology, St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 | |
Division of Neurology , Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Thunder Bay Regional Health Sciences Centre | |
Thunder Bay, Ontario, Canada, P7B 6V4 | |
McMaster Clinic | |
Hamilton, Ontario, Canada, L8L 2X2 | |
Canada, Quebec | |
Montreal Neurological Institute | |
Montreal, Quebec, Canada, H3A 2B4 | |
India, Andhra Pradesh | |
Department of Neurology, Apollo Hospitals | |
Hyderabad, Andhra Pradesh, India, 500033 | |
Department of Neurology, Care Hospital | |
Hyderabad, Andhra Pradesh, India, 500001 | |
Krishna Institute of Medical Sciences | |
Hyderabad, Andhra Pradesh, India, 500003 | |
Department of Neurology, Nizam's Institute of Medical Science | |
Hyderabad, Andhra Pradesh, India, 500082 | |
India, Delhi | |
Max Super Speciality Hospital | |
New Delhi, Delhi, India, 110017 | |
India, Karnataka | |
M S Ramaiah Memorial Hospital | |
Bangalore, Karnataka, India, 560054 | |
India, Punjab | |
Christian Medical College & Hospital | |
Ludhiana, Punjab, India, 141008 | |
India, Tamilnadu | |
Department of Neurology, Christian Medical College | |
Vellore, Tamilnadu, India, 632004 | |
India, West Bengal | |
AMRI Hospital | |
Kolkata, West Bengal, India, 700029 | |
Department of Neurology, B.P.Poddar Hospital & Medical Research Ltd | |
Kolkata, West Bengal, India, 700053 |
Principal Investigator: | 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 |
Responsible Party: | Stem Cell Therapeutics Corp. ( Alan Moore / President & Chief Executive Officer ) |
Study ID Numbers: | NTx™-265-CP-201-IS (CA) |
Study First Received: | April 18, 2008 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00663416 History of Changes |
Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee; India: Drugs Controller General of India; India: Institutional Review Board |
Epoetin Alfa Cerebral Infarction Hematinics Stroke Vascular Diseases |
Central Nervous System Diseases Ischemia Chorionic Gonadotropin Brain Diseases Cerebrovascular Disorders |
Epoetin Alfa Hematinics Hematologic Agents Stroke Nervous System Diseases Physiological Effects of Drugs Vascular Diseases Central Nervous System Diseases |
Reproductive Control Agents Brain Diseases Chorionic Gonadotropin Cerebrovascular Disorders Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases |