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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NP001
NP001
Placebo
Sponsored by
Neuraltus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic, Scottsdale
  • UC, Irvine
  • UCLA
  • California Pacific Med Center Forbes Norris MDA/ALS Research and Treatment Center
  • Mayo Clinic, Jacksonville
  • The Emory Clinic
  • University of Kansas Medical Center, Landon Center on Aging
  • University of Kentucky, Department of Neurology
  • Massachusetts General Hospital
  • Columbia University
  • SUNY Upstate Medical University, Syracuse
  • Carolinas Medical Center
  • Duke University, Dept of Neurology
  • Cleveland Clinic
  • Providence ALS Center
  • Methodist Hospital Research Institute, Methodist Neurologic Institute
  • Providence Saint Peter Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose NP001

High dose NP001

Placebo

Arm Description

Low drug dose

High drug dose

normal saline

Outcomes

Primary Outcome Measures

To evaluate the effects of NP001 on measures of clinical function

Secondary Outcome Measures

Safety and tolerability in ALS
Pulmonary function and biomarkers

Full Information

First Posted
January 17, 2011
Last Updated
November 20, 2012
Sponsor
Neuraltus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01281631
Brief Title
A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Official Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuraltus Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose NP001
Arm Type
Experimental
Arm Description
Low drug dose
Arm Title
High dose NP001
Arm Type
Experimental
Arm Description
High drug dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
normal saline
Intervention Type
Drug
Intervention Name(s)
NP001
Intervention Description
Low dose of NP001
Intervention Type
Drug
Intervention Name(s)
NP001
Intervention Description
High dose of NP001
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
normal saline
Primary Outcome Measure Information:
Title
To evaluate the effects of NP001 on measures of clinical function
Time Frame
over 9 months
Secondary Outcome Measure Information:
Title
Safety and tolerability in ALS
Time Frame
duration of study
Title
Pulmonary function and biomarkers
Time Frame
over 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G. Miller, MD
Organizational Affiliation
Forbes Norris ALS Treatment and Research, California Pacific Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic, Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
UC, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868-4281
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
California Pacific Med Center Forbes Norris MDA/ALS Research and Treatment Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Mayo Clinic, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Kansas Medical Center, Landon Center on Aging
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky, Department of Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Upstate Medical University, Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University, Dept of Neurology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence ALS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Methodist Hospital Research Institute, Methodist Neurologic Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Providence Saint Peter Hospital
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States

12. IPD Sharing Statement

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

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