Purpose

Protocol PL101-ALS501: This EAP will provide access to pridopidine for up to 200 patients with ALS who are ineligible for clinical trials.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Amyotrophic Lateral Sclerosis (ALS): - 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.

Exclusion Criteria

ALS: - 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.

Study Design

Phase
Study Type
Expanded Access

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233

Barrow Neurological Institute
Phoenix, Arizona 85013

University of California, San Diego Health
La Jolla, California 92037-0886

UC Irvine
Orange, California 92868

California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
San Francisco, California 94109

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045

Hospital for Special Care
New Britain, Connecticut 06053

Nova Southeastern University
Fort Lauderdale, Florida 33314

Mayo Clinic Jacksonville
Jacksonville, Florida 32224

University of South Florida
Tampa, Florida 33612

Northwestern University
Chicago, Illinois 60611

University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242

The University of Kansas Medical Center
Kansas City, Kansas 66160

Massachusetts General Hospital
Boston, Massachusetts 02114

Lahey Hospital Medical Center
Burlington, Massachusetts 08105

University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655

Essentia Health
Duluth, Minnesota 55805

University of Minnesota
Minneapolis, Minnesota 55455

Mayo Clinic Rochester
Rochester, Minnesota 55905

Washington University
Saint Louis, Missouri 63110

Columbia University
New York, New York 10032

Stony Brook University Hospital
Stony Brook, New York 11794

SUNY Upstate
Syracuse, New York 13210

Duke University
Durham, North Carolina 27705

OhioHealth
Columbus, Ohio 43214

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania 19140

Texas Neurology
Dallas, Texas 75206

UT Southwestern Medical Center
Dallas, Texas 75390

Virginia Commonwealth University
Richmond, Virginia 23298

Medical College of Wisconsin
Milwaukee, Wisconsin 53226

CHALS-CCT Program, UPR-MSC
San Juan, Puerto Rico 00935

More Details

NCT ID
NCT06069934
Status
No longer available
Sponsor
Prilenia

Detailed Description

ALS: Pridopidine will be given at a dose of 45 mg twice daily p.o. (or via feeding tube) over a 2-week up-titration period; followed by pridopidine 45 mg twice daily p.o. (or via feeding tube) for the remainder of the treatment period (through Week 104). Each patient will be followed for 2 years with regularly scheduled visits. The screening and baseline visits will be performed in person; subsequent visits may occur in person or remotely. Recommended in-person visits will occur at Weeks 12, 52, 78, and end of treatment (Week 104 or early termination). If the patient is unable to complete the visits in person, these visits may also be completed remotely.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.