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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Vertex Pharmaceuticals Incorporated
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT02669849
First received: January 21, 2016
Last updated: July 11, 2017
Last verified: July 2017
  Purpose
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 Intervention Phase
Cervical Spinal Cord Injury Drug: VX-210 Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Change from baseline in upper extremity motor score (UEMS) [ Time Frame: at 6 months after treatment ]

Secondary Outcome Measures:
  • 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 ISNCSCI Exam [ Time Frame: from baseline to 6 months after treatment ]
  • 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 ]

Estimated Enrollment: 150
Study Start Date: February 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 9-mg VX-210
a single 9-mg dose of VX-210 in fibrin sealant
Drug: VX-210
Experimental: Placebo
a placebo (buffer solution) in fibrin sealant
Drug: Placebo

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
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/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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02669849

Contacts
Contact: Medical Information 617-341-6777 medicalinfo@vrtx.com

  Show 28 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
  More Information

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT02669849     History of Changes
Other Study ID Numbers: VX15-210-101
Study First Received: January 21, 2016
Last Updated: July 11, 2017

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 22, 2017