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A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With ALS

Study Purpose:

The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase III

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT04248465

Neals Affiliated?

No

Coordinating Center Contact Information


Alexion Pharmaceuticals Inc. / .(JavaScript must be enabled to view this email address) / 855-752-2356
.(JavaScript must be enabled to view this email address)

Full Study Summary:

Study Sponsor:

Alexion Pharmaceuticals

Participant Duration:

Estimated Enrollment:

354

Estimated Study Start Date:

03/30/2020

Estimated Study Completion Date:

10/31/2024

Posting Last Modified Date:

07/24/2020

Date Study Added to alsconsortium.org:

02/03/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Min Vital Capacity (% predicted normal):

    65

    Time since Symptom Onset:

    <36 months

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    1. A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
    2. ALS onset ≤ 36 months from Screening.
    3. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
    4. Upright slow vital capacity ≥ 65% predicted at Screening.
    5. If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles).
    6. Body weight ≥ 40 kilograms at Screening.
    7. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    Exclusion Criteria:

    1. History of Neisseria meningitidis infection.
    2. Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer).
    3. Dependence on invasive or non-invasive mechanical ventilation.
    4. Previously or currently treated with a complement inhibitor.
    5. Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater.

  • Site Contact Information

    Neuromuscular Research Center and Clinic
    Phoenix, Arizona 85028
    United States

    University of South Florida
    Tampa, Florida 33612
    United States

    Massachusetts General Hospital
    Boston, Massachusetts 02114
    United States

    Las Vegas Clinic
    Las Vegas, Nevada 89145
    United States

    Austin Neuromuscular Center
    Austin, Texas 78756
    United States

    Nerve & Muscle Center of Texas
    Houston, Texas 77030
    United States

    Montreal Neurological Institute and Hospital
    Montreal, Quebec H3A 2B4
    Canada