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

November 20, 2012 updated by: Neuraltus Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic, Scottsdale
    • California
      • Irvine, California, United States, 92868-4281
        • UC, Irvine
      • Los Angeles, California, United States, 90095
        • UCLA
      • San Francisco, California, United States, 94115
        • California Pacific Med Center Forbes Norris MDA/ALS Research and Treatment Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic, Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center, Landon Center on Aging
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • University of Kentucky, Department of Neurology
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University, Syracuse
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27705
        • Duke University, Dept of Neurology
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence ALS Center
    • Texas
      • Houston, Texas, United States, 77030
        • Methodist Hospital Research Institute, Methodist Neurologic Institute
    • Washington
      • Centralia, Washington, United States, 98531
        • Providence Saint Peter Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
normal saline
Drug: Placebo
normal saline
Experimental: Low dose NP001
Low drug dose
Drug: NP001
Low dose of NP001
Drug: NP001
High dose of NP001
Experimental: High dose NP001
High drug dose
Drug: NP001
Low dose of NP001
Drug: NP001
High dose of NP001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effects of NP001 on measures of clinical function
Time Frame: over 9 months
over 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability in ALS
Time Frame: duration of study
duration of study
Pulmonary function and biomarkers
Time Frame: over 9 months
over 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuraltus Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Robert G. Miller, MD, Forbes Norris ALS Treatment and Research, California Pacific Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 17, 2011

First Submitted That Met QC Criteria

January 21, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 20, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP001-10-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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