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Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation
NCT02794857 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NP001
Study Locations (20)
California
- Cedars-Sinai Medical Center — Los Angeles
- University of California, Irvine, Department of Neurology — Orange
- Forbes Norris MDA/ALS Research Center, CPMC — San Francisco
Arizona
- St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics — Phoenix
- Mayo Clinic Arizona — Scottsdale
Florida
- Mayo Clinic Florida — Jacksonville
- University of Miami Miller School of Medicine — Miami
North Carolina
- Carolinas Medical Center, Neurosciences Instutite-Neurology — Charlotte
- Duke Neurological Disorders Clinic at Morreene Road — Durham
Ohio
- Cleveland Clinic Foundation-Cleveland Clinic Hospital — Cleveland
- The Ohio State University Wexner Medical Center — Columbus
Georgia
- Emory University, Department of Neurology — Atlanta
Kansas
- University of Kansas Medical Center — Kansas City
Kentucky
- University of Kentucky, Albert B. Chandler Medical Center — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2016-08-29 |
| Est. Completion | 2017-12-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02794857
The ClinicalTrials.gov registry entry for NCT02794857 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neuraltus Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02794857 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02794857 about?
NCT02794857 is a clinical study titled "Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation". 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.
What is the current status of trial NCT02794857?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2016-08-29. Estimated completion is 2017-12-12.
What conditions does trial NCT02794857 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02794857?
The interventions under investigation include: Placebo (DRUG), NP001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02794857?
This trial is sponsored by Neuraltus Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02794857 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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