Trial record 1 of 1 for:
nct00893867
Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke (MACSI)
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| ClinicalTrials.gov Identifier: NCT00893867 |
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Recruitment Status :
Terminated
(The result of a pre-planned interim futility analysis)
First Posted : May 6, 2009
Last Update Posted : October 24, 2012
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Sponsor:
D-Pharm Ltd.
Information provided by (Responsible Party):
D-Pharm Ltd.
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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 consecutive days in total) is effective in improving long term outcome. Patients will be followed up for 3 months after the stroke.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Ischemic Stroke | Drug: DP-b99 Drug: Placebo | Phase 3 |
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 for 4 consecutive days, in acute ischemic stroke patients with an entry National Institutes of Health Stroke Scale (NIHSS) score of 10-16 and a clinical syndrome that includes at least 1 of the following: language dysfunction, visual field defect or Extinction and Inattention (formerly Neglect) (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11). An interim analysis for futility will be performed after Day 90 (or last available observation) primary endpoint data have been collected on about 45% of subjects planned to be enrolled. Clinical trial material (CTM) will be administered within 9 hours after the onset of acute ischemic stroke symptoms. Subjects will be randomized at a ratio of 1:1 to receive either DP-b99 or placebo. A data and safety monitoring board (DSMB) will assess the accumulating safety data periodically and will oversee the interim futility analysis.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 446 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Double Blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Phase 3 Pivotal Study to Assess the Safety and Efficacy of 1mg/kg/Day Intravenous DP-b99 Over 4 Consecutive Days Versus Placebo When Initiated Within Nine Hours of Acute Ischemic Stroke Onset |
| Study Start Date : | December 2009 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | April 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Ischemic Stroke
| Arm | Intervention/treatment |
|---|---|
| Experimental: DP-b99 |
Drug: DP-b99
1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset. |
| Placebo Comparator: Mannitol |
Drug: Placebo
1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset. |
Primary Outcome Measures :
- Modified Rankin Scale (mRS) categorical analysis ("shift") [ Time Frame: 90 days ]
Secondary Outcome Measures :
- Recovery, defined as a score of ≤ 1 on modified Rankin Score [ Time Frame: 90 days ]
- Safety and tolerability [ Time Frame: throughout study - baseline until day 90 ]the numbers of patients with treatment-emergent adverse events, results of physical examination, 12-lead electrocardiogram, vital signs and laboratory tests (complete blood count, chemistry and urinalysis)
- recovery as assessed by an NIHSS of not more than 1 [ Time Frame: 90 days ]
- 'home time' [ Time Frame: 90 days ]exploratory endpoint of 'home time', which measures the length of time (as number of nights)spent at home/relatives' home between hospital discharge and day 90
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- M or F age 18 - 85, inclusive
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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
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893867
Locations
Show 154 study locations
Sponsors and Collaborators
D-Pharm Ltd.
Investigators
| Principal Investigator: | Ashfaq Shuaib, MD | University of Alberta Hospital, Edmonton, Canada | |
| Principal Investigator: | Vasco Salgado, MD | Hospital Professor Doutor Fernando Fonseca, EPE, Amadora, Portugal | |
| Principal Investigator: | Philippe Lyrer, Prof. Dr. | Universitätsspital Basel, Neurologie, Basel, Switzerland | |
| Principal Investigator: | Tobien Schreuder, MD | Atrium MC Parkstad, Heerlen, Netherlands | |
| Principal Investigator: | Maria S Rocha, MD | Hospital Santa Marcelina, Sao Paulo, Brasil | |
| Principal Investigator: | Hugues Chabriat, Prof. | Hôpital Lariboisière - Service Neurologie, Paris, France |
Publications:
| Responsible Party: | D-Pharm Ltd. |
| ClinicalTrials.gov Identifier: | NCT00893867 |
| Other Study ID Numbers: |
Ptcl-01373 |
| First Posted: | May 6, 2009 Key Record Dates |
| Last Update Posted: | October 24, 2012 |
| Last Verified: | October 2012 |
Keywords provided by D-Pharm Ltd.:
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acute ischemic stroke neuroprotective agent |
Additional relevant MeSH terms:
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Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |