|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 |
| 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
|
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:
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:
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 | |
| 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 |
More Information
| 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 Hematologic Agents Physiological Effects of Drugs Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases |
Reproductive Control Agents Brain Diseases Chorionic Gonadotropin Cerebrovascular Disorders Pharmacologic Actions Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction |