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NCT02611674 · ClinicalTrials.gov registry record
Methodology Study of Novel Outcome Measures to Assess Progression of ALS
A clinical trial, sponsored by Biogen.
- Completed
- Registry status
- 138
- Enrollment target
NCT02611674: Completed study, sponsored by Biogen.
NCT02611674 is a clinical trial that has completed, run by Biogen. The registered enrollment target is 138 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02611674 has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- 138 participants
- Enrollment target
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.
Primary Outcome
EIM is an electrophysiological technique in which current is applied to a muscle of interest and resultant voltage and impedance are measured. These measured parameters reflect the conductivity of underlying tissue and presumably the pathologic state of denervated muscle in an ALS participant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2016-01-06 |
| Est. Completion | 2019-08-01 |
What the finished NCT02611674 record still lists
NCT02611674 is an observational study that tracks outcomes without assigning an intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02611674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02611674 about?
NCT02611674 is a clinical study titled "Methodology Study of Novel Outcome Measures to Assess Progression of ALS". 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 t...
What is the current status of trial NCT02611674?
This trial is currently completed. The enrollment target is 138 participants. The study started on 2016-01-06. Estimated completion is 2019-08-01.
Who is sponsoring clinical trial NCT02611674?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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