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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injury Drug: VX-210 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: VX-210 Drug: VX-210



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-210 [ Time Frame: up to 53 hours post-treatment ]
  7. Maximum Observed Plasma Concentration (Cmax) of VX-210 [ Time Frame: up to 53 hours post-treatment ]
  8. Area Under Plasma Concentration Time Curve (AUC) of VX-210 [ Time Frame: up to 53 hours post-treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669849


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Fresno, California, United States
Orange, California, United States
Sacramento, California, United States
United States, Florida
Jacksonville, Florida, United States
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Savannah, Georgia, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, Ohio
Columbus, Ohio, United States
Toledo, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Falls Church, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
United States, Washington
Seattle, Washington, United States
Canada, British Colombia
Vancouver, British Colombia, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Québec, Quebec, Canada
Canada
Saskatoon, Canada
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
  Study Documents (Full-Text)

Documents provided by Vertex Pharmaceuticals Incorporated:
Study Protocol  [PDF] April 14, 2017
Statistical Analysis Plan  [PDF] January 15, 2019


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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT02669849    
Other Study ID Numbers: VX15-210-101
First Posted: February 1, 2016    Key Record Dates
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System