NCT00927953

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2009

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 7, 2012

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

June 24, 2009

Results QC Date

April 10, 2012

Last Update Submit

February 4, 2022

Conditions

West Nile Neuroinvasive DiseaseWest Nile Virus InfectionEncephalitisMeningitisAcute Flaccid ParalysisWest Nile Fever

Keywords

West Nile virusWNVEncephalitisMeningitisAcute Flaccid ParalysisMonoclonal AntibodyWNNDWest Nile FeverWNF

Outcome Measures

Primary Outcomes (2)

  • The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)

    The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows: * 0 = No symptoms at all * 1 = No significant disability despite symptoms; * 2 = Slight disability; * 3 = Moderate disability; * 4 = Moderately severe disability; * 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6 = Dead

    Study Day 2, 7, 14, 28, and 120

  • The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event

    Includes adverse events considered possibly, probably, or definitely related to study drug

    120 days

Secondary Outcomes (3)

  • The Number of Participants With a Favorable Neurologic Outcome

    Study Day 2, 7, 14, 28, and 120

  • Mean Modified Rankin Scale Scores

    Study Day 0, 2, 7, 14, 28, and 120

  • Time to a >= 1 Point Reduction in the Modified Rankin Scale Score

    Study Day 2, 7, 14, 28, and 120

Study Arms (2)

MGAWN1

EXPERIMENTAL

30 mg/kg single intravenous infusion of MGAWN1

Biological: MGAWN1

Placebo - Normal Saline

PLACEBO COMPARATOR

single intravenous infusion of saline placebo

Biological: Placebo - normal saline

Interventions

MGAWN1BIOLOGICAL

Humanized monoclonal to West Nile virus. Dose = 30 mg/kg actual body weight intravenous, one dose at Day 0.

MGAWN1
Placebo - normal salineBIOLOGICAL

Normal Saline intravenous, volume same as active comparator, one dose at Day 0

Placebo - Normal Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide written informed consent
  • Be \>=18 years of age at the time of enrollment
  • Have West Nile Fever defined as:
  • temperature \>38°C, headache, AND
  • 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)
  • Encephalopathy (depressed or altered level of consciousness, lethargy, or personality change lasting 24 hours)
  • CSF pleocytosis \>=5 cells/mm\^3
  • AND/OR
  • West Nile meningitis (must meet criteria c and d)
  • Clinical signs of meningeal inflammation, including nuchal rigidity, Kernig or Brudzinski sign, photophobia, or phonophobia
  • CSF pleocytosis \>=5 cells/mm\^3
  • AND/OR
  • Acute flaccid paralysis (must meet criteria e and f)
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

West Nile FeverEncephalitisMeningitisacute flaccid myelitis

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Limitations and Caveats

Early termination due to the inability to enroll (only 13 of 120 subjects enrolled); leading to small numbers of subjects analyzed and therefore many pre-specified analyses were not performed.

Results Point of Contact

Title
Medical Officer
Organization
MacroGenics, Inc.
info@macrogenics.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 25, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2011

Study Completion

May 1, 2011

Last Updated

February 10, 2022

Results First Posted

November 7, 2012

Record last verified: 2022-01