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

Study Purpose:

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Study Director: Medical Director, Biogen

Clinicaltrials.gov ID (11 digit #):

NCT02611674

Neals Affiliated?

No

Coordinating Center Contact Information


Biogen / .(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) United States

Full 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 novel 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 Sponsor:

Biogen

Participant Duration:

Estimated Enrollment:

100

Estimated Study Start Date:

01/06/2016

Estimated Study Completion Date:

09/09/2019

Posting Last Modified Date:

05/17/2017

Date Study Added to alsconsortium.org:

01/26/2016
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Time since Symptom Onset:

    <24

    Time since Diagnosis:

    Can participants use Riluzole?


    Study Population:
    Participants suffering from ALS are recruited by participating physicians in a standard clinical practice setting.

    Key Inclusion Criteria:
    -A diagnosis of sporadic or familial ALS
    -ALS onset within ≤2 years

    Key Exclusion Criteria:
    -History of or positive test result at Screening for human immunodeficiency virus (HIV)
    -History of or positive test result at Screening for hepatitis C virus (HCV) antibody or hepatitis B virus ([HBV]
    -Possibility of neuromuscular weakness other than ALS
    -Unspecified reasons that, in the opinion of the site Investigator, make the subject unsuitable for enrollment or unlikely to be able to complete, at a minimum, the Month 6 Visit

    NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply

  • Site Contact Information

    Barrow Neurological Institute
    Phoenix, Arizona 85013
    United States

    California Pacific Medical Center
    San Francisco, California 94115
    United States

    Compass Research Main
    Orlando , Florida 32806
    United States

    Johns Hopkins Hospital
    Baltimore, Maryland 21287
    United States

    Massachusetts General Hospital
    Boston, Massachusetts 02114
    United States

    Mayo Clinic - Rochester
    Rochester, Minnesota 55905
    United States

    Penn State Milton S. Hershey Medical Center
    Jen Crossen; Anne Morris / .(JavaScript must be enabled to view this email address) / 717-531-0003 ext.280842; 717-531-0003 ext. 289123
    30 Hope Drive
    Hershey, Pennsylvania 17033
    United States

    The Emory Clinic
    Atlanta, Georgia 30322
    United States

    University of California San Diego Medical Center
    San Diego, California 92103
    United States

    University of South Florida
    Tampa, Florida 33612
    United States

    University of Virginia
    Charlottesville, Virginia 22908
    United States

    Washington University School of Medicine
    Saint Louis, Missouri 63110
    United States

    UZ Leuven
    Leuven, Belgium 3000
    Belgium

    Montreal Neurological Institute Clinical Research Unit
    Montreal, Quebec H3A 2B4
    Canada

    Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5
    Canada

    Kantonsspital St. Gallen
    St. Gallen, Switzerland 9007
    Switzerland

    Universitaetsklinikum Jena
    Jena, Germany 7747
    Germany

    Universitaetsklinikum Ulm
    Ulm, Germany 89081
    Germany

    Medizinische Hochschule Hannover
    Hannover, Germany 30625
    Germany

    Charite - Campus Virchow-Klinikum
    Berlin, Germany 13125
    Germany

    Groupe Hospitalier Pitie-Salpetriere
    Paris, France 75013
    France

    Hopital Gui de Chauliac, Service de Neurologie
    Hérault, France 34295
    France

    Royal Hallamshire Hospital
    West Midlands, United Kingdom S102HQ
    United Kingdom

    Beaumont Hospital
    Dublin , Ireland Dublin 9
    Ireland

    UMC Utrecht
    CX Utrecht, Netherlands 3584
    Netherlands