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

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ClinicalTrials.gov Identifier: NCT02669849
Recruitment Status : Terminated
First Posted : February 1, 2016
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Tracking Information
First Submitted Date  ICMJE January 21, 2016
First Posted Date  ICMJE February 1, 2016
Results First Submitted Date  ICMJE November 29, 2019
Results First Posted Date  ICMJE January 22, 2020
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
Change in Upper Extremity Motor Score (UEMS) [ Time Frame: From baseline at 6 months post-treatment ]
UEMS focuses selectively on the hand and arm control most relevant to individuals with a cervical spinal cord injury. UEMS ranges from 0 to 50, where a higher score indicates a better movement of hand and arm.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
Change from baseline in upper extremity motor score (UEMS) [ Time Frame: at 6 months after treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • Spinal Cord Independence Measure (SCIM) III Self-Care Subscore [ Time Frame: At 6 months post-treatment ]
    SCIM self-care subscore measures self-care abilities (feeding, dressing, grooming, bathing), respiration and sphincter management and mobility. The score ranges from 0-20, where a higher score represents a better outcome.
  • Capabilities of Upper Extremity Test (CUE-T) Score [ Time Frame: At 6 months post-treatment ]
    CUE-T measures a participant's ability to perform specific functional movements/tasks with the arms and hands (for example: grasping a pencil, pushing or lifting a weight). CUE-T score ranges from 0-128, where a higher score indicates an improvement in participant's ability.
  • Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension Score [ Time Frame: At 6 months post-treatment ]
    GRASSP measures participant's ability to perform specific functional tasks with the arms, hands, and fingers. GRASSP quantitative prehension score ranges from 0-60, where a higher score indicates a better performance.
  • Percentage of American Spinal Injury Association Impairment Scale (AIS) Grade Responders [ Time Frame: At 6 months post-treatment ]
    AIS ranks impairment according to body-wide motor/sensory results: Grade A: Complete (no sensory or motor function is preserved in the sacral segments S4 to 5); Grade B: Sensory Incomplete (sensory but not motor function is preserved below the neurological level and includes the sacral segments S4 to 5); Grade C: Motor Incomplete (motor function is preserved at the most caudal sacral segments); Grade D: Motor Incomplete (motor incomplete status as defined above, with at least half or more of key muscle functions below the single neurological level of injury having a muscle grade >=3; Grade E: Normal (sensation and motor function as tested are graded as normal in all segments). An AIS responder was defined as a subject with improvement by ≥2 AIS grades (i.e., baseline AIS Grade A changed to Grade C, D, or E; baseline AIS Grade B changed to D or E at 6 months after treatment).
  • Percentage of Motor Level Responders [ Time Frame: At 6 months post-treatment ]
    The motor level score for the right or left side assesses contraction strength of 10 key muscles in the upper and lower extremities on each side of the body; each muscle receives a score from 0 (total paralysis) to 5 ([normal] active movement). A motor level responder was defined as a subject with improvement by ≥2 motor levels on either side of the body (i.e., baseline level C4 changed to C6, C7, C8 on the left; or baseline level C5 changed to C7, C8 on the right).
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-210 [ Time Frame: up to 53 hours post-treatment ]
  • Maximum Observed Plasma Concentration (Cmax) of VX-210 [ Time Frame: up to 53 hours post-treatment ]
  • Area Under Plasma Concentration Time Curve (AUC) of VX-210 [ Time Frame: up to 53 hours post-treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • Spinal Cord Independence Measure (SCIM) III Self-Care subscore [ Time Frame: at 6 months after treatment ]
  • Capabilities of Upper Extremity Test (CUE-T) score [ Time Frame: at 6 months after treatment ]
  • Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension score [ Time Frame: at 6 months after treatment ]
  • American Spinal Injury Association Impairment Scale (AIS) grade conversion [ Time Frame: from baseline to 6 months after treatment ]
  • Motor level change using The ASIA Impairment Scale (AIS) [ Time Frame: from baseline to 6 months after treatment ]
    Patient motor level at screening using The ASIA Impairment Scale (AIS)
  • Pharmacokinetic (PK) parameters of VX-210: tmax (time of the maximum concentration) [ Time Frame: 48 hours after treatment ]
  • Pharmacokinetic (PK) parameters of VX-210: Cmax (maximum observed concentration) [ Time Frame: 48 hours after treatment ]
  • Pharmacokinetic (PK) parameters of VX-210: AUC (Area Under plasma Concentration ) [ Time Frame: 48 hours after treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervical Spinal Cord Injury
Intervention  ICMJE
  • Drug: VX-210
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: VX-210
    Intervention: Drug: VX-210
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 10, 2020)
70
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2016)
150
Actual Study Completion Date  ICMJE November 2018
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02669849
Other Study ID Numbers  ICMJE VX15-210-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vertex Pharmaceuticals Incorporated
Study Sponsor  ICMJE Vertex Pharmaceuticals Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vertex Pharmaceuticals Incorporated
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP