A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2)
- Conditions
- Amyotrophic Lateral Sclerosis
- Registration Number
- NCT06069934
- Lead Sponsor
- Prilenia
- 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.
- 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.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
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 (32)
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
Nova Southeastern University
๐บ๐ธFort Lauderdale, Florida, United States
Mayo Clinic Jacksonville
๐บ๐ธJacksonville, Florida, United States
University of South Florida
๐บ๐ธTampa, Florida, United States
Northwestern University
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
Columbia University
๐บ๐ธNew York, New York, United States
Stony Brook University Hospital
๐บ๐ธStony Brook, New York, United States
Mayo Clinic Rochester
๐บ๐ธRochester, Minnesota, United States
Washington University
๐บ๐ธSaint Louis, Missouri, United States
SUNY Upstate
๐บ๐ธSyracuse, New York, United States
Duke University
๐บ๐ธDurham, North Carolina, United States
OhioHealth
๐บ๐ธColumbus, Ohio, United States
Thomas Jefferson University
๐บ๐ธPhiladelphia, Pennsylvania, United States
Lewis Katz School of Medicine at Temple University
๐บ๐ธPhiladelphia, Pennsylvania, United States
Texas Neurology
๐บ๐ธDallas, Texas, United States
UT Southwestern Medical Center
๐บ๐ธDallas, Texas, United States
Virginia Commonwealth University
๐บ๐ธRichmond, Virginia, United States
Medical College of Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States
CHALS-CCT Program, UPR-MSC
๐ต๐ทSan Juan, Puerto Rico