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Methodology Study of Novel Outcome Measures to Assess Progression of ALS

NCT02611674 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2019-10-24

No results posted yet for this study

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
16 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-06
Primary Completion
2018-07-27
Completion
2019-08-01

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611674 on ClinicalTrials.gov