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| Sponsored by: |
Stem Cell Therapeutics Corp. |
| Information provided by: | Stem Cell Therapeutics Corp. |
| ClinicalTrials.gov Identifier: | NCT00663416 |
Purpose
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 |
| ChemIDplus related topics: | Epoetin alfa Erythropoietin Sodium chloride Chorionic gonadotropin Choriogonadotropin Alfa Chlorides |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II 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
|
Eligibility
| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female patient is either:
Exclusion Criteria:
Contacts and Locations| 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 | |||||
| Division of Neurology , Sunnybrook Health Sciences Centre | |||||
| Toronto, Ontario, Canada, M4N 3M5 | |||||
| Department of Neurology, St. Michael's Hospital | |||||
| Toronto, Ontario, Canada, M5B 1W8 | |||||
| University Health Network | |||||
| Toronto, Ontario, Canada, M5T 2S8 | |||||
| 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 | |||||
| Stem Cell Therapeutics Corp. |
| 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 |
More Information
| Responsible Party: | Stem Cell Therapeutics Corp. ( Alan Moore / President & Chief Executive Officer ) |
| Study ID Numbers: | NTx™-265-CP-201-IS (CA) |
| First Received: | April 18, 2008 |
| Last Updated: | September 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00663416 |
| Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee |
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