Trial Search Results

An Efficacy and Safety Study of Ravulizumab in ALS Participants

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Alexion Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Placebo
  • Biological: Ravulizumab

Phase:

Phase 3

Eligibility


Key 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.

Key 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting