A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.
Condition or disease
Amyotrophic Lateral Sclerosis
Drug: NP001Drug: Placebo
This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS conducted in multiple centers. Drug or placebo will be given intravenously. Approximately 105 subjects will be enrolled. Subjects will be allocated (1:1:1) to placebo and 2 dose levels of NP001.
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Layout table for eligibility information
Ages Eligible for Study:
21 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria. A list of key criteria is listed below:
Onset of symptoms less than 3 years prior to study entry.
Forced Vital Capacity (FVC) at least 70% of that predicted for age and height.
Stable dose 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.
Unstable medical condition(s) other than ALS.
Life expectancy of less than 6 months.
Require life-sustaining interventions for the 6 months following randomization.
Have a tracheotomy or be using ventilatory assistance [including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)].
Active pulmonary disease.
Immune modulator therapy within 12 weeks of study entry or participation in studies of other agents within the last 4 weeks prior to the randomization.