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

• Status: Terminated
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Criteria

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/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.