Protocol PL101-ALS501: This EAP will provide access to pridopidine for up to 200 patients with ALS who are ineligible for clinical trials.
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.
Study Type
EXPANDED_ACCESS
Pridopidine 45 mg hard gelatin capsules once daily p.o. (or via feeding tube)
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
University of California, San Diego Health
La Jolla, California, United States
UC Irvine
Orange, California, United States
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Hospital for Special Care
New Britain, Connecticut, United States
Nova Southeastern University
Fort Lauderdale, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
...and 22 more locations