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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuraltus Pharmaceuticals, Inc.

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.