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)
1 other identifier
interventional
136
1 country
17
Brief Summary
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2011
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 22, 2012
November 1, 2012
1.6 years
January 17, 2011
November 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effects of NP001 on measures of clinical function
over 9 months
Secondary Outcomes (2)
Safety and tolerability in ALS
duration of study
Pulmonary function and biomarkers
over 9 months
Study Arms (3)
Low dose NP001
EXPERIMENTALLow drug dose
High dose NP001
EXPERIMENTALHigh drug dose
Placebo
PLACEBO COMPARATORnormal saline
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Mayo Clinic, Scottsdale
Scottsdale, Arizona, 85259, United States
UC, Irvine
Irvine, California, 92868-4281, United States
UCLA
Los Angeles, California, 90095, United States
California Pacific Med Center Forbes Norris MDA/ALS Research and Treatment Center
San Francisco, California, 94115, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
University of Kansas Medical Center, Landon Center on Aging
Kansas City, Kansas, 66160, United States
University of Kentucky, Department of Neurology
Lexington, Kentucky, 40536-0284, United States
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
Columbia University
New York, New York, 10032, United States
SUNY Upstate Medical University, Syracuse
Syracuse, New York, 13210, United States
Carolinas Medical Center
Charlotte, North Carolina, 28207, United States
Duke University, Dept of Neurology
Durham, North Carolina, 27705, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Providence ALS Center
Portland, Oregon, 97213, United States
Methodist Hospital Research Institute, Methodist Neurologic Institute
Houston, Texas, 77030, United States
Providence Saint Peter Hospital
Centralia, Washington, 98531, United States
Related Publications (1)
Forrest BD, Goyal NA, Fleming TR, Bracci PM, Brett NR, Khan Z, Robinson M, Azhir A, McGrath M. The Effectiveness of NP001 on the Long-Term Survival of Patients with Amyotrophic Lateral Sclerosis. Biomedicines. 2024 Oct 16;12(10):2367. doi: 10.3390/biomedicines12102367.
PMID: 39457678DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert G. Miller, MD
Forbes Norris ALS Treatment and Research, California Pacific Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2011
First Posted
January 24, 2011
Study Start
February 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
November 22, 2012
Record last verified: 2012-11