Last updated on May 2018

Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Amyotrophic Lateral Sclerosis
  • Age: Between 21 - 80 Years
  • Gender: Male or Female
  • Other:
    Key Inclusion Criteria:
    Diagnosis of clinically possible, clinically probable (with or without laboratory
    upport), or clinically definite ALS (using the revised El Escorial Criteria)
    Forced vital capacity greater than or equal to 65% of that predicted for age and
    height
    Onset of ALS-related weakness less than 3 years prior to first dose of study drug
    Plasma high sensitivity C-reactive protein (hs-CRP) concentration of greater than or
    equal to 0.113 mg/dL at pre-screening/screening
    Stable dose (greater than 30 days) of riluzole if undergoing treatment with this
    agent
    For females: Not be of childbearing potential or agree to use adequate birth control
    during the study
    Key Exclusion Criteria:
    Life expectancy of less than 6 months
    Tracheotomy or be using ventilatory assistance, including Bi-level Positive Airway
    Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)
    Active pulmonary disease
    Gastrostomy
    Stem cell therapy
    Immune modulator therapy or participation in studies of other agents within 12 weeks
    of pre-screening/screening
    Unstable medical condition other than ALS

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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