A Study of New Outcome Measures to Assess the Progression of Amyotrophic Lateral Sclerosis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-007438
NCT ID: NCT02611674
Sponsor Protocol Number: 999AS003
About this study
The purpose of this study is to evaluate and rank-order a set of new outcome measures administered to patients with amyotrophic lateral sclerosis (ALS), in order to identify measures that are more sensitive to disease progression than the current Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- A diagnosis of sporadic or familial ALS
- ALS onset within ≤ 2 years
Exclusion Criteria
- History of or a positive test result at screening for human immunodeficiency virus (HIV)
- History of or a positive test result at screening for hepatitis C virus (HCV) antibody or hepatitis B virus (HBV)
- Possibility of neuromuscular weakness other than ALS
- Unspecified reasons that, in the opinion of the site Investigator, make the subject unsuitable for enrollment or unlikely to be able to complete, at a minimum, the month 6 visit
- Other protocol defined inclusion/ exclusion criteria may apply
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Eric Sorenson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available