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Completed No phase listed Observational

Methodology Study of Novel Outcome Measures to Assess Progression of ALS

ClinicalTrials.gov ID: NCT02611674

Public ClinicalTrials.gov record NCT02611674. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 11:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Methodology Study of Novel Electrophysiological, Physical, and Imaging Outcome Measures to Assess the Progression of Amyotrophic Lateral Sclerosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02611674
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Biogen
Industry
Enrollment
138 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
16 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 5, 2016
Primary completion
Jul 26, 2018
Completion
Jul 31, 2019
Last update posted
Oct 23, 2019

2016 – 2019

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
University of California San Diego Medical Center San Diego California 92103
California Pacific Medical Center San Francisco California 94115
University of South Florida Tampa Florida 33612
The Emory Clinic Atlanta Georgia 30322
Johns Hopkins Hospital Baltimore Maryland 21287
Massachusetts General Hospital, MA Charlestown Massachusetts 2129
Washington University School of Medicine St Louis Missouri 63110
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania EC037

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02611674, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 23, 2019 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02611674 live on ClinicalTrials.gov.

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