Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Neuraltus Pharmaceuticals, Inc.
This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS and evidence of elevated systemic inflammation. Subjects will be allocated (1:1) to NP001 and placebo. Drug or placebo will be given intravenously.
Age
21–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of clinically possible, clinically probable (with or without laboratory support), 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
You may not be if
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
Clareo Health | Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation
