Status:
TERMINATED
Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke
Lead Sponsor:
D-Pharm Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3 additional days (4 co...
Detailed Description
This will be a randomized, double-blind, placebo-controlled, multicenter, multi-national, parallel-arm, pivotal study comparing a placebo group to a DP-b99 group treated with intravenous 1.0 mg/kg/d f...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- M or F age 18 - 85, inclusive
- Suffered an acute, likely hemispheric, ischemic stroke, defined as acute, focal, neurological deficit(s), secondary to a presumed vascular event, which must include at least one of the following components (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 3, 9 or 11):
- Visual
- Best Language
- Extinction and Inattention (formerly Neglect)
- Suffered the onset of an acute ischemic stroke that can be evaluated and treatment initiated within 9 hours after the onset of acute ischemic stroke symptoms.
- Screening NIHSS score of 10 to 16, inclusive
- Readily accessible peripheral venous access for clinical trial material (CTM) administration and blood sampling
- Ability to understand the requirements of the study and be willing to provide written informed consent as evidenced by signature on an informed consent document approved by an institutional review board or independent ethics committee, and agree to abide by the study restrictions and return for the required assessments.
- Provided written authorization for use and disclosure of protected health information in accordance with the Health Insurance Portability and Accountability Act in the United States and the Personal Information Protection and Electronic Documents Act in Canada
- Exclusion Criteria:
- An intracerebral or subarachnoid hemorrhage per screening/baseline computerized tomography scan or susceptibility-weighted magnetic resonance imaging
- A candidate for either:
- thrombolytic therapy, or have been treated with thrombolytic therapy for the current stroke
- mechanical thromboembolectomy, or have been treated with mechanical thromboembolectomy for the current stroke
- Delirious, comatose or stuporous or demented, or having a mental impairment that in the investigator's opinion renders the subject incapable to participate in the study
- Have seizure(s) anytime from stroke onset to screening/baseline NIHSS evaluation
- Neurological or non-neurological comorbidities that in the investigator's opinion may lead, independent of the current stroke, to further deterioration in the subject's neurological status during the trial period, or may render the study's neurological assessments inconclusive for the purpose of evaluating solely the stroke's effects
- Likely to undergo a procedure involving cardiopulmonary bypass during the study period
- Suffered a myocardial infarction in the last 90 days
- Any medical condition that in the investigator's opinion may threaten the subject's ability to complete the study (e.g., concurrent significant or life-threatening diseases, such as malignancies or end stage organ failure)
- Rapid spontaneous improvement of neurological signs during screening/baseline assessments
- Premorbid neurological deficits and functional limitations assessed by a pre-stroke Modified Rankin Scale score of \> 1
- Suffered a stroke within 90 days of the screening/baseline assessments that is either diagnostically confirmed or assumed to be in the same cerebral territory as is the current acute stroke
- Either severe hypertension or hypotension, as measured by at least 2 consecutive supine measurements taken 10 minutes apart prior to randomization.
- Significant current renal or hepatic disease(s): a serum creatinine concentration of \>2.5 mg/dL; alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase values that are three times greater than the upper limit of normal.
- Have a platelet count of \<100,000/mm3 or, for patients on oral anticoagulants at study entry, INR of \>4
- Female of childbearing potential who is not willing to use adequate and effective birth control measures for the duration of the trial. Effective birth control measures include hormonal contraception, a barrier method such as a diaphragm, intrauterine device and/or condom with spermicide
- Positive urine pregnancy test at screening/baseline or be a lactating female
- Currently dependent on, or abusing, alcohol or one or more of the following: sympathomimetic amines, cannabis, cocaine, hallucinogens, inhalants, opioids, phencyclidine, sedatives and hypnotics
- Received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication or have previously participated in a clinical trial involving DP-b99
- Severe anemia as measured by a hemoglobin value of \< 7 g/dl.
- In a dependent relationship with the physician or the study sponsor.
- Known hypersensitivity to any component of the investigational product.
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT00893867
Start Date
December 1 2009
End Date
April 1 2012
Last Update
October 24 2012
Active Locations (154)
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1
Research Center of Southern California
Oceanside, California, United States
2
Associated Neurologists, P.C.
Danbury, Connecticut, United States
3
Memorial Health University Medical Center
Savannah, Georgia, United States
4
The University of Kentucky The Methodist Hospital
Lexington, Kentucky, United States