Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
NCT ID: NCT02669849
Last Updated: 2020-01-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
70 participants
INTERVENTIONAL
2016-07-31
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
VX-210
VX-210
Interventions
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VX-210
Placebo
Eligibility Criteria
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Inclusion Criteria
* Screening UEMS score must be ≤16 points on each side.
* AIS A subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and T1 on at least 1 side.
* AIS B subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and C7 on at least 1 side.
* American Spinal Injury Association Impairment Scale (AIS) grade A or AIS grade B.
* Scheduled and planned to undergo a spinal decompression/stabilization surgery that commences within 72 hours after the initial injury.
* Computed tomography (CT) scan or magnetic resonance imaging (MRI) is consistent with the subject's neurological deficit.
Exclusion Criteria
* Inability to undergo decompression/stabilization surgery that commences within 72 hours after injury.
* One or more upper extremity muscle groups untestable during screening ISNCSCI examination.
* Acute SCI from gunshot or penetrating/stab wound; non-traumatic SCI (e.g., transverse myelitis, acute disc herniation); brachial plexus injury; complete spinal cord transection; or multifocal SCI.
* Females who are breastfeeding or have a positive serum pregnancy test.
* Body mass index (BMI) of ≥40 kg/m\^2 at screening.
* History of an adverse reaction to a fibrin sealant or its components.
* Unconsciousness or other mental impairment that precludes reliable International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) examination.
* Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs.
* Any significant medical or psychiatric comorbidities that would significantly increase the risk of study enrollment and/or significantly interfere with study outcomes or assessments, in the judgment of the investigator.
14 Years
75 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
Fresno, California, United States
Orange, California, United States
Sacramento, California, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Falls Church, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Seattle, Washington, United States
Vancouver, British Colombia, Canada
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VX15-210-101
Identifier Type: -
Identifier Source: org_study_id
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