Pridopidine in Amyotrophic Lateral Sclerosis (EAP 2)
- Conditions
- Amyotrophic Lateral Sclerosis
- Registration Number
- NCT06069934
- Lead Sponsor
- Prilenia
- Brief Summary
This EAP will provide access to pridopidine for up to 200 patients with ALS who are ineligible for clinical trials. Pridopidine will be given at a dose of 45 mg twice daily p.o. (or via feeding tube).
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
University of Alabama at Birmingham
๐บ๐ธBirmingham, Alabama, United States
Barrow Neurological Institute
๐บ๐ธPhoenix, Arizona, United States
University of California, San Diego Health
๐บ๐ธLa Jolla, California, United States
UC Irvine
๐บ๐ธOrange, California, United States
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
๐บ๐ธSan Francisco, California, United States
University of Colorado Anschutz Medical Campus
๐บ๐ธAurora, Colorado, United States
Hospital for Special Care
๐บ๐ธNew Britain, Connecticut, United States
Georgetown University Medical Center
๐บ๐ธWashington, District of Columbia, United States
Nova Southeastern University
๐บ๐ธFort Lauderdale, Florida, United States
University of South Florida
๐บ๐ธTampa, Florida, United States
Saint Alphonsus Regional Medical Center
๐บ๐ธBoise, Idaho, United States
Northwestern University
๐บ๐ธChicago, Illinois, United States
The University of Chicago
๐บ๐ธChicago, Illinois, United States
University of Iowa Hospitals and Clinics
๐บ๐ธIowa City, Iowa, United States
The University of Kansas Medical Center
๐บ๐ธKansas City, Kansas, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
Lahey Hospital Medical Center
๐บ๐ธBurlington, Massachusetts, United States
University of Massachusetts Chan Medical School
๐บ๐ธWorcester, Massachusetts, United States
Essentia Health
๐บ๐ธDuluth, Minnesota, United States
University of Minnesota
๐บ๐ธMinneapolis, Minnesota, United States
Mayo Clinic Rochester
๐บ๐ธRochester, Minnesota, United States
Washington University
๐บ๐ธSaint Louis, Missouri, United States
Hackensack University Medical Center
๐บ๐ธHackensack, New Jersey, United States
SUNY Upstate
๐บ๐ธSyracuse, New York, United States
Stony Brook University Hospital
๐บ๐ธStony Brook, New York, United States
University of North Carolina at Chapel Hill
๐บ๐ธChapel Hill, North Carolina, United States
Duke University
๐บ๐ธDurham, North Carolina, United States
OhioHealth
๐บ๐ธColumbus, Ohio, United States
Providence ALS Clinic
๐บ๐ธPortland, Oregon, United States
Thomas Jefferson University
๐บ๐ธPhiladelphia, Pennsylvania, United States
Lewis Katz School of Medicine at Temple University
๐บ๐ธPhiladelphia, Pennsylvania, United States
Austinl Neuromuscular Center
๐บ๐ธAustin, Texas, United States
Texas Neurology
๐บ๐ธDallas, Texas, United States
UT Southwestern Medical Center
๐บ๐ธDallas, Texas, United States
Nerve and Muscle Center of Texas
๐บ๐ธHouston, Texas, United States
Virginia Commonwealth University
๐บ๐ธRichmond, Virginia, United States
(CAMC) Charleston Area Medical Center
๐บ๐ธCharleston, West Virginia, United States
UW Health University Hospital
๐บ๐ธMadison, Wisconsin, United States
Medical College of Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States
CHALS-CCT Program, UPR-MSC
๐ต๐ทSan Juan, Puerto Rico