PLS Natural History Study (PNHS)

Study Purpose:

The purpose of this study is to improve the current research status of Primary Lateral Sclerosis (PLS) by studying the natural history of the disease to determine how it progresses without any drug treatment. The study will investigate natural history of disease by dividing participants into two groups: early PLS (less than 4 years since symptom onset) and well-established PLS (more than 4 but less than 15 years since symptom onset). We’re hoping that information gained from this project will prepare the research community for future clinical trials in PLS.

Disease:

Primary Lateral Sclerosis (PLS)

Study Type:

Observational Study

Study Category:

Study Status:

Enrolling

Phase:

Not Applicable

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

Hiroshi Mitsumoto, MD, DSc, Columbia University

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

No

Coordinating Center Contact Information

Columbia University
Grace Jang / .(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) New York, New York United States

Full Study Summary:

Over 1 year, you will return to clinic every 6 months and complete a telephone call every 3 months. You will have one follow-up phone call at the 2-year mark. Procedures include routine physical and neurological examinations, breathing tests, questionnaires assessing your functional abilities and psychological health, cognitive testing, an electromyography (EMG) test, blood collection, and at-home urine collection.

Study Sponsor:

ALS Association (ALSA), Mitsubishi Tanabe Pharma, and the Spastic Paraplegia Foundation (SPF), and Mr. David Marren and his family

Participant Duration:

2 years

Estimated Enrollment:

100

Estimated Study Start Date:

Estimated Study Completion Date:

07/15/2023

Posting Last Modified Date:

04/04/2022

Date Study Added to alsconsortium.org:

04/04/2022
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    25

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    • Have been diagnosed with Primary Lateral Sclerosis (PLS)
    • Have symptoms that started within the last 15 years
    • Are at least 25 years old
    • No history of ALS or PLS in immediate family
    • No family history of Hereditary Spastic Paraplegia (HSP)

    There are additional eligiblity criteria.

  • Site Contact Information

    Cedars-Sinai Medical Center
    Sophia Mostowy / .(JavaScript must be enabled to view this email address) / Los Angeles, California
    United States

    University of California, Irvine
    Marie Wencel / .(JavaScript must be enabled to view this email address) / Orange, California
    United States

    University of California, Davis
    Omaid Sarwary / .(JavaScript must be enabled to view this email address) / Sacramento, California
    United States

    University of California, San Francisco
    Hannah George / .(JavaScript must be enabled to view this email address) / San Francisco, California
    United States

    University of Florida, Gainesville
    Julie Segura / .(JavaScript must be enabled to view this email address) / Gainesville, Florida
    United States

    Mayo Clinic
    Megan Donahue / .(JavaScript must be enabled to view this email address) / Jacksonville, Florida
    United States

    University of Florida, Jacksonville
    Deepa Nagaraju / .(JavaScript must be enabled to view this email address) / Jacksonville, Florida
    United States

    Emory University
    Karon Simmons / .(JavaScript must be enabled to view this email address) / Atlanta, Georgia
    United States

    Northwestern University
    Emma Schmidt / .(JavaScript must be enabled to view this email address) / Chicago, Illinois
    United States

    University of Kansas
    Katheryn Jennens / .(JavaScript must be enabled to view this email address) / Fairway, Kansas
    United States

    University of Kentucky
    Deborah Taylor / .(JavaScript must be enabled to view this email address) / Lexington, Kentucky
    United States

    Johns Hopkins University
    Betsy Mosmiller / .(JavaScript must be enabled to view this email address) / Baltimore, Maryland
    United States

    Massachusetts General Hospital
    Mia Resendes / .(JavaScript must be enabled to view this email address) / Boston, Massachusetts
    United States

    University of Michigan
    Ann Arbor, Michigan
    United States

    University of Minnesota
    Sarah Hilbert / .(JavaScript must be enabled to view this email address) / Minneapolis, Minnesota
    United States

    Mayo Clinic
    Jane Sultze / .(JavaScript must be enabled to view this email address) / Rochester, Minnesota
    United States

    St. Louis University
    Rachel Grant / .(JavaScript must be enabled to view this email address) / St. Louis, Missouri
    United States

    University of Nebraska Medical Center
    Deborah Heimes / .(JavaScript must be enabled to view this email address) / Omaha, Nebraska
    United States

    Columbia University
    Grace Jang / .(JavaScript must be enabled to view this email address) / New York, New York
    United States

    Mount Sinai, Beth Israel
    Kevin Van Geem / .(JavaScript must be enabled to view this email address) / ew York, New York
    United States

    Ohio State University
    Misty Green / .(JavaScript must be enabled to view this email address) / Columbus, Ohio
    United States

    Penn State University
    Abid Kazi / .(JavaScript must be enabled to view this email address) / Hershey, Pennsylvania
    United States

    Temple University
    John Furey / .(JavaScript must be enabled to view this email address) / Philadephia, Pennsylvania
    United States

    University of Pennsylvania
    Adreeja GuhaRay / .(JavaScript must be enabled to view this email address) / Philadephia, Pennsylvania
    United States

    Texas Neurology
    Mohamad Nasri / .(JavaScript must be enabled to view this email address) / Dallas, Texas
    United States

    Virginia Commonwealth University
    Sierra "Bronwyn" Murray / .(JavaScript must be enabled to view this email address) / Henrico, Virginia
    United States

    University of Alberta
    Kelsey Tymkow / .(JavaScript must be enabled to view this email address) / Edmonton, Alberta
    Canada

    London Health Sciences
    Denise Hulley / .(JavaScript must be enabled to view this email address) / London, Ontario
    Canada

    McGill University
    Cyrena Gerardi / .(JavaScript must be enabled to view this email address) / Montreal, Quebec
    Canada

    University of Toronto, Sunnybrook
    Shirley Pham / .(JavaScript must be enabled to view this email address) / Sunnybrook, Toronto
    Canada