Status and phase
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About
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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:
Inclusion Criteria:
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
136 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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