A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2)
Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (PL101-ALS501)
1 other identifier
expanded_access
N/A
2 countries
32
Brief Summary
Protocol PL101-ALS501: This EAP will provide access to pridopidine for up to 200 patients with ALS who are ineligible for clinical trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedMay 18, 2025
April 1, 2025
September 27, 2023
May 14, 2025
Conditions
Keywords
Interventions
Pridopidine 45 mg hard gelatin capsules once daily p.o. (or via feeding tube)
Eligibility Criteria
You may qualify if:
- Sporadic or familial ALS.
- Patient does not qualify for clinical trials of pridopidine or as per site investigator's opinion, and is not medically or geographically suitable for other clinical trials.
- Capable of providing informed consent and complying with study procedures, in the site investigator's opinion.
- Patient has established care with a physician at a specialized ALS center involved in the study and will maintain this clinical care throughout the duration of the EAP.
- Pridopidine naive patients must have a life expectancy of at least 6 months in the site investigator's opinion.
You may not qualify if:
- Confirmed prolonged Fridericia-corrected QT (QTcF) interval (\>450 ms for men; \>470 ms for women).
- Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, asymptomatic sustained ventricular tachycardia, or left bundle branch block.
- Known history of long QT syndrome or a first degree relative with long QT syndrome.
- Use of prohibited medications within the 4 weeks prior to baseline.
- Use of Nuedexta (\>20 mg dextromethorphan and \>10 mg quinidine twice daily); citalopram \>20 mg/day; escitalopram \>10 mg/day.
- Known allergy to pridopidine or any of the exipients (silicified microcrystalline cellulose, magnesium stearate).
- History of any clinically significant or unstable medical condition or laboratory abnormality that, based on site investigator's judgment, may interfere with assessment of the study objectives.
- Female who is pregnant or nursing or who plans to get pregnant during the course of the EAP.
- Female of child-bearing potential or male unwilling or unable to use accepted methods of birth control.
- Use of investigational treatments for ALS (as part of participation in a clinical trial or another EAP) within 5 half-lives (if known) or 30 days (whichever is longer) prior to screening (other than pridopidine).
- Patient receives or has received any gene or cell-based therapy.
- Active cancer or history of cancer, except for basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
- Patients who chose to take experimental medications and/or supplements, and for whom this is the only reason they are not eligible for trials.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prilenialead
- Massachusetts General Hospitalcollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (32)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
University of California, San Diego Health
La Jolla, California, 92037-0886, United States
UC Irvine
Orange, California, 92868, United States
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
San Francisco, California, 94109, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Hospital for Special Care
New Britain, Connecticut, 06053, United States
Nova Southeastern University
Fort Lauderdale, Florida, 33314, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
University of South Florida
Tampa, Florida, 33612, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Lahey Hospital Medical Center
Burlington, Massachusetts, 08105, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655, United States
Essentia Health
Duluth, Minnesota, 55805, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Columbia University
New York, New York, 10032, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
SUNY Upstate
Syracuse, New York, 13210, United States
Duke University
Durham, North Carolina, 27705, United States
OhioHealth
Columbus, Ohio, 43214, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140, United States
Texas Neurology
Dallas, Texas, 75206, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
CHALS-CCT Program, UPR-MSC
San Juan, 00935, Puerto Rico