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Cervical Spinal Cord InjuryPhase 2/3NCT02669849

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

A Phase 2/3 study testing VX-210 in people with Cervical Spinal Cord Injury, run by Vertex Pharmaceuticals Incorporated at 39 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Cervical Spinal Cord Injury
What is being tested?
VX-210
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
39 sitesin 2 countries
Study dates
Jul 2016to Nov 2018
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

United States33 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Ann Arbor, Michigan

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Falls Church, Virginia

  • Study site

    Fresno, California

  • Study site

    Hershey, Pennsylvania

  • Study site

    Iowa City, Iowa

  • Study site

    Jackson, Mississippi

  • Study site

    Jacksonville, Florida

  • Study site

    Louisville, Kentucky

  • Study site

    Minneapolis, Minnesota

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Providence, Rhode Island

  • Study site

    Richmond, Virginia

  • Study site

    Roanoke, Virginia

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Savannah, Georgia

  • Study site

    Seattle, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Toledo, Ohio

  • Study site

    Tucson, Arizona

Other trials in United States

Canada6 sites

  • Study site

    Halifax, Nova Scotia

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Saskatoon

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Colombia

Other trials in Canada

About this study

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

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.

Being tested
VX-210, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VX-210Drug

  • PlaceboDrug

Study groups in NCT02669849
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
VX-210ExperimentalNot described
Receives: Drug: VX-210

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Upper Extremity Motor Score (UEMS)

    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.

    Measured: From baseline at 6 months post-treatment

Secondary outcomes (8)

  1. Spinal Cord Independence Measure (SCIM) III Self-Care Subscore

    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.

    Measured: At 6 months post-treatment

  2. Capabilities of Upper Extremity Test (CUE-T) Score

    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.

    Measured: At 6 months post-treatment

  3. Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension Score

    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.

    Measured: At 6 months post-treatment

  4. Percentage of American Spinal Injury Association Impairment Scale (AIS) Grade Responders

    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).

    Measured: At 6 months post-treatment

  5. Percentage of Motor Level Responders

    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).

    Measured: At 6 months post-treatment

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-210

    Measured: up to 53 hours post-treatment

  7. Maximum Observed Plasma Concentration (Cmax) of VX-210

    Measured: up to 53 hours post-treatment

  8. Area Under Plasma Concentration Time Curve (AUC) of VX-210

    Measured: up to 53 hours post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionNov 2018
  4. Study completionNov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02669849
Sponsor's protocol ID
VX15-210-101
Status last verified
Jan 2020
First submitted
21 Jan 2016
Last updated
22 Jan 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing VX-210 in people with Cervical Spinal Cord Injury, run by Vertex Pharmaceuticals Incorporated at 39 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Upper Extremity Motor Score (UEMS) (time frame: From baseline at 6 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02669849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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