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

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ClinicalTrials.gov Identifier: NCT01281631
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
Neuraltus Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: NP001 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : February 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose NP001
Low drug dose
 Drug: NP001
Low dose of NP001
Experimental: High dose NP001
High drug dose
 Drug: NP001
High dose of NP001
Placebo Comparator: Placebo
normal saline
 Drug: Placebo
normal saline


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the effects of NP001 on measures of clinical function [ Time Frame: over 9 months ]

Secondary Outcome Measures :
  1. Safety and tolerability in ALS [ Time Frame: duration of study ]
  2. Pulmonary function and biomarkers [ Time Frame: over 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281631


Locations
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Sponsors and Collaborators
Neuraltus Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Robert G. Miller, MD Forbes Norris ALS Treatment and Research, California Pacific Medical Center
More Information
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Responsible Party: Neuraltus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01281631    
Other Study ID Numbers: NP001-10-002
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012
Keywords provided by Neuraltus Pharmaceuticals, Inc.:
ALS
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases