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



Status:Terminated
Conditions:Hospital, Women's Studies
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:14 - 75
Updated:12/26/2018
Start Date:February 2016
End Date:November 2018

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A Phase 2b/3, Double-blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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/m2 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.
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34
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