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
πΊπΈBirmingham, Alabama, United States
Barrow Neurological Institute
πΊπΈPhoenix, Arizona, United States
University of California, San Diego Health
πΊπΈLa Jolla, California, United States
UC Irvine
πΊπΈOrange, California, United States
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
πΊπΈSan Francisco, California, United States
University of Colorado Anschutz Medical Campus
πΊπΈAurora, Colorado, United States
Hospital for Special Care
πΊπΈNew Britain, Connecticut, United States
Nova Southeastern University
πΊπΈFort Lauderdale, Florida, United States
Mayo Clinic Jacksonville
πΊπΈJacksonville, Florida, United States
University of South Florida
πΊπΈTampa, Florida, United States
Scroll for more (22 remaining)University of Alabama at BirminghamπΊπΈBirmingham, Alabama, United States