Methodology Study of Novel Outcome Measures to Assess Progression of ALS
Completed
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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.
Key facts
- Study ID
- NCT02611674
- Run by
- Biogen
- People needed
- 138
- Starts
- 2016-01-06
- Expected to finish
- 2019-08-01
- Last updated by the study team
- 2019-10-24
Who can join
Age: 16 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California San Diego Medical Center — San Diego, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- University of South Florida — Tampa, Florida, United States
- The Emory Clinic — Atlanta, Georgia, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Massachusetts General Hospital, MA — Charlestown, Massachusetts, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
- UZ Leuven — Leuven, Belgium
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
- Montreal Neurological Institute Clinical Research Unit — Montreal, Quebec, Canada
- Hopital Gui de Chauliac, Service de Neurologie — Montpellier, Hérault, France
- Groupe Hospitalier Pitie-Salpetriere — Paris, Paris, France
- Charite - Campus Virchow-Klinikum — Berlin, Germany
- Medizinische Hochschule Hannover — Hanover, Germany
- Universitaetsklinikum Jena — Jena, Germany
- Universitaetsklinikum Ulm — Ulm, Germany
- Beaumont Hospital — Dublin, Ireland
- UMC Utrecht — Utrecht, CX, Netherlands
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland
- Royal Hallamshire Hospital — Sheffield, West Midlands, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.