Clinical Trial Details

NCT ID: NCT02794857
Date Last Changed: February 8, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of NP001 and Placebo to evaluate Amyotrophic Lateral Sclerosis

Research Study Title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS) and Evidence of Elevated Systemic Inflammation

Purpose

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.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
21 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Neuraltus Pharmaceuticals, Inc.
Duration
13 Months
Facility Type
N/A
Compensation

Eligibility

All ages 21 Years to 80 Years

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

Site Locations (18)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85013 St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Ashley Reece
602-406-4775
Ashley.Reece@dignityhealth.org

Shafeeq Ladha, MD
Principal Investigator
United States Arizona Scottsdale 85259 Mayo Clinic Arizona
Alisa Powell
480-301-8788
powell.alisa@mayo.edu

Mark Ross, MD
Principal Investigator
United States California Los Angeles 90048 Cedars-Sinai Medical Center
Vy Nguyen
424-315-2361
vy.nguyenx@cshs.org

Richard Lewis, MD
Principal Investigator
United States California Orange 92862 University of California, Irvine, Department of Neurology
Veena Mathew
714-456-2864
vmathew@uci.edu

Namita Goyal, MD
Principal Investigator
United States California San Francisco 94115 Forbes Norris MDA/ALS Research Center, CPMC
Dallas A. Forshew, RN, BSN
415-309-5178
ForsheD@cpmcri.org

Jonathan S. Katz, MD
Principal Investigator
United States Florida Jacksonville 32224 Mayo Clinic Florida
Carla Palmucci, B.A.
904-953-3182
Palmucci.Carla@mayo.edu

Bjorn E. Oskarsson, MD
Principal Investigator
United States Florida Miami 33136 University of Miami Miller School of Medicine
Julie Steele, RN
305-243-7336
jsteele@med.miami.edu

Michael Benatar, MD
Principal Investigator
United States Georgia Atlanta 30322 Emory University, Department of Neurology
Meraida Polak, RN
404-778-3807
mpolak@emory.edu

Christina Fournier, MD
Principal Investigator
United States Kansas Kansas City 66160 University of Kansas Medical Center
Christy Nichols
913-945-9945
Cnichols2@kumc.edu

Richard J. Barohn, MD
Principal Investigator
United States Kentucky Lexington 40536-0293 University of Kentucky, Albert B. Chandler Medical Center
Meghann Bruno, RN, BSN
859-218-5064
Meghann.bruno@uky.edu

Edward J. Kasarskis, MD, PhD
Principal Investigator
United States Massachusetts Boston 02114 Massachusetts General Hospital
Leah Miller
617-724-7398
lmiller33@partners.org

James Berry, MD, MPH
Principal Investigator
United States Minnesota Minneapolis 55414 Clinical & Translational Science Institute, University of Minnesota
Susan Rolandelli, RN
612-624-7745
cnru@umn.edu

Georgios Manousakis, MD
Principal Investigator
United States North Carolina Charlotte 28207 Carolinas Medical Center, Neurosciences Instutite-Neurology
Cynthia Lary, RN
704-446-6063
Cynthia.lary@carolinashealthcare.org

Benjamin Brooks, MD
Principal Investigator
United States North Carolina Durham 27705 Duke Neurological Disorders Clinic at Morreene Road
Karen Grace, RN
919-668-2844
karen.grace@duke.edu

Richard Bedlack, MD, PhD, MS
Principal Investigator
United States Ohio Cleveland 44195 Cleveland Clinic Foundation-Cleveland Clinic Hospital
Irys B. Caristo
216-444-0173
Caristi@ccf.org

Erik P. Pioro, MD, PhD
Principal Investigator
United States Oregon Portland 97213 Providence Brain & Spine Institute, ALS Center
Arlena Georgeson
503-962-1171
arlena.georgeson@providence.org

Kimberly Goslin, MD, PhD
Principal Investigator
United States Texas Houston 77030 Houston Methodist Neurological Institute
Luis F. Lay, Jr., CCRC
713-441-3057
LFLayjr@houstonmethodist.org

Ericka Simpson, MD
Principal Investigator
Canada Quebec Montreal H3A 2B4 Montreal Neurological Institute
Kristiana Salmon
514-398-1779
kristiana.salmon@mcgill.ca

Angela Genge, MD
Principal Investigator

Contact

Frances Faurot
415-912-1981
E-mail:

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