NCT01281631CompletedPhase 2
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Neuraltus Pharmaceuticals, Inc.17 sites in 1 country136 target enrollmentStarted: February 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 136
- Locations
- 17
- Primary Endpoint
- To evaluate the effects of NP001 on measures of clinical function
Study Overview
Brief Summary
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Low dose NP001
Experimental
Low drug dose
Intervention: NP001 (Drug)
High dose NP001
Experimental
High drug dose
Intervention: NP001 (Drug)
Placebo
Placebo Comparator
normal saline
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
To evaluate the effects of NP001 on measures of clinical function
Time Frame: over 9 months
Secondary Outcomes
- Pulmonary function and biomarkers(over 9 months)
- Safety and tolerability in ALS(duration of study)
Investigators
Study Sites (17)
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