Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Cervical Spinal Cord Injury

In brief

The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific evaluation of the effects of VX-210 on neurological recovery and daily function after spinal cord injury.

Key facts

Study ID

NCT02669849

Run by

Vertex Pharmaceuticals Incorporated

People needed

70

Starts

2016-07-01

Expected to finish

2018-11-01

Last updated by the study team

2020-01-22

Who can join

Age: 14 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute traumatic cervical SCI, motor level of C4, C5, C6, or C7 on each side:
• 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.

You may not qualify if…

• Participation in any other clinical study for acute SCI without approval by the sponsor.
• 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.
• Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Fresno, California, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Iowa City, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Jackson, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Columbus, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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