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View Clinical Trial (Medical Research Study)
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Treatment of West Nile Virus With MGAWN1 - NCT00927953-83404 (Clinical Trial 299731)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy299731.aspx
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| City: |
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Idaho Falls |
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State:
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ID |
| Zip Code: |
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83404 |
| Conditions: |
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West Nile Neuroinvasive Disease - West Nile Virus Infection - Encephalitis - Meningitis - Acute Flaccid Paralysis |
| Purpose: |
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This study will test a drug called MGAWN1 for the treatment of West Nile infections of the
brain and spinal cord.
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| Study summary: |
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The objective of this study is to evaluate the safety, efficacy, and pharmacokinetics of
MGAWN1 in subjects with a syndrome compatible with West Nile Neuroinvasive Disease (WNND)
[encephalitis, meningitis, or acute flaccid paralysis]. Subjects can be enrolled based on a
syndrome compatible with WNND, and do not need documented West Nile virus infection. |
| Criteria: |
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Inclusion Criteria:
1. Provide written informed consent
2. Be ≥18 years of age at the time of enrollment
3. Have neurological signs and symptoms of West Nile meningitis, encephalitis, and/or
acute flaccid paralysis, defined as:
• West Nile encephalitis (must meet criteria a and b)
1. Encephalopathy (depressed or altered level of consciousness, lethargy, or
personality change lasting 24 hours)
2. CSF pleocytosis ≥5 cells/mm^3 (≥0.005 × 10^9 cells/L)
AND/OR
• West Nile meningitis (must meet criteria c and d)
3. Clinical signs of meningeal inflammation, including nuchal rigidity, Kernig or
Brudzinski sign, photophobia, or phonophobia
4. CSF pleocytosis ≥5 cells/mm^3 (≥0.005 × 10^9 cells/L)
AND/OR
• Acute flaccid paralysis (must meet criteria e and f)
5. Acute onset of limb weakness with marked progression over 48 hours
6. Two or more of the following conditions:
- asymmetry to weakness
- areflexia or hyporeflexia of affected limb(s)
- absence of pain, paresthesia, or numbness in affected limb(s)
- CSF pleocytosis ≥5 cells/mm^3 (≥0.005 × 10^9 cells/L)
- CSF elevated protein levels (4.5 g/L)
- electrodiagnostic studies consistent with an anterior horn cell process
- or abnormal increased signal in the anterior gray matter as documented by
spinal cord magnetic resonance imaging
4. Have epidemiological factors consistent with WNV infection (must meet criterion a or
b):
1. Appropriate time of year for WNV transmission in region
2. Travel history to a region where WNV is active
5. Develop neurological signs and symptoms within 4 days before study enrollment
6. If female of childbearing potential or male and in a sexual relationship with a
female of childbearing potential, agree (or have partner agree) to either abstinence
or to use 2 of the following methods of contraception for 120 days (approximately 4
months) after study drug administration:
1. Oral contraceptives, or other form of hormonal birth control including hormonal
vaginal rings or transdermal patches
2. An intrauterine device
3. Barrier contraception (condom) with a spermicide (i.e., female subject ensures
use by male partner[s])
4. Any other equivalent method of contraception (as judged by the investigative
team).
Exclusion Criteria:
1. Have clinical signs of advanced CNS dysfunction, as assessed by GCS of 3−5
2. Have received ribavirin or interferon alpha within 15 days before study enrollment or
plan to receive during the study period
3. Have an underlying medical condition that could cause symptoms of encephalitis,
meningitis, or acute flaccid paralysis as judged by the investigator
4. Have gastrointestinal or respiratory symptoms that are not consistent with WNV
infections as judged by the investigator
5. Have a history of severe allergic reaction to humanized monoclonal antibodies
6. Have other laboratory parameters suggestive of a non-viral cause of the subject's
medical condition, including but not limited to:
1. CSF (if performed) gram stain positive for organisms
2. CSF (if performed) glucose <70 mg/dL
7. Are pregnant or breastfeeding. Females of childbearing potential must have a negative
urine pregnancy test within 4 days before study enrollment.
8. Have received any investigational drug within 30 days
9. Have any condition that in the investigator's opinion would increase the risk to the
subject while undergoing treatment with MGAWN1 or otherwise warrant exclusion from
the study |
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| Study is available at: |
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Eastern Idaho Regional Medical Center
Idaho Falls, ID 83404
United States
Primary Contact:
Kimberly Fielding
Phone: 208-535-8404
Secondary Contact:
Lara Blake
Email: wnv@macrogenics.com
Phone: 301-354-3819 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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