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.
Study Status:
Recruiting
Disease:
Primary Lateral Sclerosis (PLS)
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Hiroshi Mitsumoto, MD, DSc, Columbia University
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Columbia University
Grace Jang / email hidden; JavaScript is required
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 Completion Date:
07 / 15 / 2023
Posting Last Modified Date:
04 / 04 / 2022
Date Study Added to neals.org:
04 / 04 / 2022
Minimum Age:
25
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.
Cedars-Sinai Medical Center
Sophia Mostowy / email hidden; JavaScript is required
Los Angeles, California
United States
University of California, Irvine
Marie Wencel / email hidden; JavaScript is required
Orange, California
United States
University of California, Davis
Omaid Sarwary / email hidden; JavaScript is required
Sacramento, California
United States
University of California, San Francisco
Hannah George / email hidden; JavaScript is required
San Francisco, California
United States
University of Florida, Gainesville
Julie Segura / email hidden; JavaScript is required
Gainesville, Florida
United States
Mayo Clinic
Megan Donahue / email hidden; JavaScript is required
Jacksonville, Florida
United States
University of Florida, Jacksonville
Deepa Nagaraju / email hidden; JavaScript is required
Jacksonville, Florida
United States
Emory University
Karon Simmons / email hidden; JavaScript is required
Atlanta, Georgia
United States
Northwestern University
Emma Schmidt / email hidden; JavaScript is required
Chicago, Illinois
United States
University of Kansas
Katheryn Jennens / email hidden; JavaScript is required
Fairway, Kansas
United States
University of Kentucky
Deborah Taylor / email hidden; JavaScript is required
Lexington, Kentucky
United States
Johns Hopkins University
Betsy Mosmiller / email hidden; JavaScript is required
Baltimore, Maryland
United States
Massachusetts General Hospital
Mia Resendes / email hidden; JavaScript is required
Boston, Massachusetts
United States
University of Michigan
Ann Arbor, Michigan
United States
University of Minnesota
Sarah Hilbert / email hidden; JavaScript is required
Minneapolis, Minnesota
United States
Mayo Clinic
Jane Sultze / email hidden; JavaScript is required
Rochester, Minnesota
United States
St. Louis University
Rachel Grant / email hidden; JavaScript is required
St. Louis, Missouri
United States
University of Nebraska Medical Center
Deborah Heimes / email hidden; JavaScript is required
Omaha, Nebraska
United States
Columbia University
Grace Jang / email hidden; JavaScript is required
New York, New York
United States
Mount Sinai, Beth Israel
Kevin Van Geem / email hidden; JavaScript is required
ew York, New York
United States
Ohio State University
Misty Green / email hidden; JavaScript is required
Columbus, Ohio
United States
Penn State University
Abid Kazi / email hidden; JavaScript is required
Hershey, Pennsylvania
United States
Temple University
John Furey / email hidden; JavaScript is required
Philadephia, Pennsylvania
United States
University of Pennsylvania
Adreeja GuhaRay / email hidden; JavaScript is required
Philadephia, Pennsylvania
United States
Texas Neurology
Mohamad Nasri / email hidden; JavaScript is required
Dallas, Texas
United States
Virginia Commonwealth University
Sierra "Bronwyn" Murray / email hidden; JavaScript is required
Henrico, Virginia
United States
University of Alberta
Kelsey Tymkow / email hidden; JavaScript is required
Edmonton, Alberta
Canada
London Health Sciences
Denise Hulley / email hidden; JavaScript is required
London, Ontario
Canada
McGill University
Cyrena Gerardi / email hidden; JavaScript is required
Montreal, Quebec
Canada
University of Toronto, Sunnybrook
Shirley Pham / email hidden; JavaScript is required
Sunnybrook, Toronto
Canada