Clinical trial NCT00927953: Treatment of West Nile Virus With MGAWN1
Official title: Phase 2, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MGAWN1 in Subjects With Laboratory-documented West Nile Fever or Suspected Central Nervous System Infection Due to West Nile Virus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: West Nile Neuroinvasive Disease
West Nile Virus Infection
Encephalitis
Meningitis
Acute Flaccid Paralysis
West Nile Fever
Keywords: West Nile virus
WNV
Encephalitis
Meningitis
Acute Flaccid Paralysis
Monoclonal Antibody
WNND
West Nile Fever
WNF
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-06-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test a drug called MGAWN1 for the treatment of West Nile infections.

Detailed description: The objective of this study is to evaluate the safety, efficacy, and pharmacokinetics of MGAWN1 in subjects with West Nile Fever or 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.

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent
2. Be \>=18 years of age at the time of enrollment
3. Have West Nile Fever defined as:

   1. temperature \>38°C, headache, AND
   2. positive diagnostic test for WNV Ribonucleic acid or Immunoglobulin M with serum or cerebrospinal fluid (CSF)

   OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as:

   • West Nile encephalitis (must meet criteria a and b below)
   1. Encephalopathy (depressed or altered level of consciousness, lethargy, or personality change lasting 24 hours)
   2. CSF pleocytosis \>=5 cells/mm\^3

      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

      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
      * 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 West Nile Virus infection (must meet criterion a or b below):

   1. Appropriate time of year for West Nile Virus transmission in region
   2. Travel history to a region where West Nile Virus is active
5. Develop signs and/or symptoms within 14 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 practice abstinence or 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 investigator)

Primary outcomes:
measure: The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
timeFrame: Study Day 2, 7, 14, 28, and 120
measure: The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event
timeFrame: 120 days
Secondary outcomes:
measure: The Number of Participants With a Favorable Neurologic Outcome
timeFrame: Study Day 2, 7, 14, 28, and 120
measure: Mean Modified Rankin Scale Scores
timeFrame: Study Day 0, 2, 7, 14, 28, and 120
measure: Time to a >= 1 Point Reduction in the Modified Rankin Scale Score
timeFrame: Study Day 2, 7, 14, 28, and 120
Other outcomes:
Locations:
Study officials:
References: