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

Vertex Pharmaceuticals

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Cervical Spinal Cord Injury

Treatments

Drug: Placebo

Drug: VX-210

Study type

Interventional

Funder types

Industry

Identifiers

NCT02669849

VX15-210-101

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

14 to 75 years old

Volunteers

No Healthy Volunteers

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.