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A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

N

Neuraltus Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: Placebo
Drug: NP001

Study type

Interventional

Funder types

Industry

Identifiers

NCT01281631
NP001-10-002

Details and patient eligibility

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

136 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy 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:

  • 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.

Exclusion Criteria:

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

136 participants in 3 patient groups, including a placebo group

Low dose NP001
Experimental group
Description:
Low drug dose
Treatment:
Drug: NP001
Drug: NP001
High dose NP001
Experimental group
Description:
High drug dose
Treatment:
Drug: NP001
Drug: NP001
Placebo
Placebo Comparator group
Description:
normal saline
Treatment:
Drug: Placebo

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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