Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neuraltus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01281631
First received: January 17, 2011
Last updated: November 20, 2012
Last verified: November 2012
History of Changes

January 17, 2011
November 20, 2012
February 2011
September 2012   (final data collection date for primary outcome measure)
To evaluate the effects of NP001 on measures of clinical function [ Time Frame: over 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01281631 on ClinicalTrials.gov Archive Site
  • Safety and tolerability in ALS [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  • Pulmonary function and biomarkers [ Time Frame: over 9 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
  • Drug: NP001
    Low dose of NP001
  • Drug: NP001
    High dose of NP001
  • Drug: Placebo
    normal saline
  • Experimental: Low dose NP001
    Low drug dose
    Intervention: Drug: NP001
  • Experimental: High dose NP001
    High drug dose
    Intervention: Drug: NP001
  • Placebo Comparator: Placebo
    normal saline
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01281631
NP001-10-002
Yes
Neuraltus Pharmaceuticals, Inc.
Neuraltus Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Robert G. Miller, MD Forbes Norris ALS Treatment and Research, California Pacific Medical Center
Neuraltus Pharmaceuticals, Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP