Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation

• Status: Completed
• Trial end date: 2017-12-12
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates NP001 in patients with amyotrophic lateral sclerosis (ALS) and evidence of systemic inflammation. Half of participants will receive NP001 and the other half will receive placebo.

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

Details

• Lead Sponsor: Neuraltus Pharmaceuticals, Inc.

Criteria

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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