Trials / Completed
CompletedNCT02611674
Methodology Study of Novel Outcome Measures to Assess Progression of ALS
Methodology Study of Novel Electrophysiological, Physical, and Imaging Outcome Measures to Assess the Progression of Amyotrophic Lateral Sclerosis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 138 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 16 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of the study are to estimate and rank-order the longitudinal standardized mean changes over 6 months and over 12 months, for a set of outcome measures administered to participants with amyotrophic lateral sclerosis (ALS), in order to identify measures that are more sensitive to disease progression than Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R). The secondary objectives of this study are: To evaluate the test-retest reproducibility of each outcome measure; To determine correlations between 6 and 12-month changes in all exploratory measures with 18 and 24-month changes in ALSFRS-R and survival; To assess correlations between/among the various measures; To obtain biological samples in order to identify molecular correlates to the clinical measures and to further characterize previously identified and novel molecular biomarkers of disease progression for incorporation into future clinical studies.
Conditions
Timeline
- Start date
- 2016-01-06
- Primary completion
- 2018-07-27
- Completion
- 2019-08-01
- First posted
- 2015-11-23
- Last updated
- 2019-10-24
Locations
21 sites across 9 countries: United States, Belgium, Canada, France, Germany, Ireland, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02611674. Inclusion in this directory is not an endorsement.