West Nile Neuroinvasive DiseasePhase 2PARADIGMNCT00927953
Treatment of West Nile Virus With MGAWN1
A Phase 2 study testing MGAWN1 in people with West Nile Neuroinvasive Disease and West Nile Virus Infection, run by MacroGenics.
Trial summary
This study will test a drug called MGAWN1 for the treatment of West Nile infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- West Nile Neuroinvasive Disease, West Nile Virus Infection, Encephalitis
- What is being tested?
- MGAWN1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- May 2009to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 33Show fewer
- 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)
- Acute onset of limb weakness with marked progression over 48 hours
- 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
- Have epidemiological factors consistent with West Nile Virus infection (must meet criterion a or b below):
- Appropriate time of year for West Nile Virus transmission in region
- Travel history to a region where West Nile Virus is active
- Develop signs and/or symptoms within 14 days before study enrollment.
- 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:
- Oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches
- An intrauterine device
- Barrier contraception (condom) with a spermicide (i.e., female subject ensures use by male partner[s])
- Any other equivalent method of contraception (as judged by the investigator)
Who cannot join
None listed.
About this study
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
This study will test a drug called MGAWN1 for the treatment of West Nile infections.
Read the 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.
- Conditions
- West Nile Neuroinvasive Disease, West Nile Virus Infection, Encephalitis, Meningitis, Acute Flaccid Paralysis, West Nile Fever
- Being tested
- MGAWN1, Placebo - normal saline
- Keywords
- West Nile virus, WNV, Encephalitis, Meningitis, Acute Flaccid Paralysis, Monoclonal Antibody, WNND, West Nile Fever, WNF
- Medical subject headings
- West Nile Fever, Encephalitis, Meningitis, acute flaccid myelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGAWN1Biological
Humanized monoclonal to West Nile virus. Dose = 30 mg/kg actual body weight intravenous, one dose at Day 0.
Placebo - normal salineBiological
Normal Saline intravenous, volume same as active comparator, one dose at Day 0
| Study group | Role | What they receive |
|---|---|---|
| MGAWN1 | Experimental | 30 mg/kg single intravenous infusion of MGAWN1 Receives: Biological: MGAWN1 |
| Placebo - Normal Saline | Placebo comparator | single intravenous infusion of saline placebo Receives: Biological: Placebo - normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 120 days
Secondary outcomes (3)
The Number of Participants With a Favorable Neurologic Outcome
Favorable neurologic outcome responders are defined as subjects whose Modified Rankin Score is <=2. 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.
Measured: Study Day 2, 7, 14, 28, and 120
Mean Modified Rankin Scale Scores
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.
Measured: Study Day 0, 2, 7, 14, 28, and 120
Time to a >= 1 Point Reduction in the Modified Rankin Scale Score
Measured: Study Day 2, 7, 14, 28, and 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2011
- Study completionMay 2011
Why it stopped: Early termination due to the inability to enroll (13 of 120 subjects enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for West Nile Neuroinvasive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927953
- Sponsor's protocol ID
- CP-MGAWN1-02
- Acronym
- PARADIGM
- Status last verified
- Jan 2022
- First submitted
- 24 Jun 2009
- Last updated
- 10 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00927953
- Acronym / sponsor ID
- PARADIGM / CP-MGAWN1-02
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to the inability to enroll (13 of 120 subjects enrolled)
- Enrolment
- 13 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Posted 7 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGAWN1 | Experimental | Biological: MGAWN130 mg/kg single intravenous infusion of MGAWN1 |
| Placebo - Normal Saline | Placebo comparator | Biological: Placebo - normal salinesingle intravenous infusion of saline placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Provide written informed consent
- Be >=18 years of age at the time of enrollment
- Have West Nile Fever defined as:
- OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as:
- AND/OR
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGAWN1Humanized monoclonal to West Nile virus. Dose = 30 mg/kg actual body weight intravenous, one dose at Day 0. | Biological | MGAWN1 |
| Placebo - normal salineNormal Saline intravenous, volume same as active comparator, one dose at Day 0 | Biological | Placebo - Normal Saline |
Primary outcome
The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
Time frame: Study Day 2, 7, 14, 28, and 120
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
The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event
Time frame: 120 days
Includes adverse events considered possibly, probably, or definitely related to study drug
3 secondary outcomes
The Number of Participants With a Favorable Neurologic Outcome
Time frame: Study Day 2, 7, 14, 28, and 120
Mean Modified Rankin Scale Scores
Time frame: Study Day 0, 2, 7, 14, 28, and 120
Time to a >= 1 Point Reduction in the Modified Rankin Scale Score
Time frame: Study Day 2, 7, 14, 28, and 120
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MGAWN1 in people with West Nile Neuroinvasive Disease and West Nile Virus Infection, run by MacroGenics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) (time frame: Study Day 2, 7, 14, 28, and 120). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.