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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02794857 |
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Date of registration:
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24/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation
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Scientific title:
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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 |
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Date of first enrolment:
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August 29, 2016 |
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Target sample size:
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138 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02794857 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Robert G. Miller, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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California Pacific Medical Center |
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Name:
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Jonathan Katz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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California Pacific Medical Center |
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Name:
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Gil Block, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neuraltus Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: NP001
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Drug: Placebo
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Primary Outcome(s)
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Change from baseline in score on ALS Functional Rating Scale-Revised (ALSFRS-R) questionnaire
[Time Frame: Baseline and 6 months]
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Secondary Outcome(s)
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Time to tracheotomy
[Time Frame: Up to 6 months]
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Change in levels of blood inflammatory biomarkers
[Time Frame: Baseline, 3 and 6 months]
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Change in pulmonary function as measured by slow vital capacity readings
[Time Frame: Baseline and 6 months]
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Secondary ID(s)
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NP001-10-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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