Shifting The PARADIGM: PrimeC, An Oral Candidate For Amyotrophic Lateral Sclerosis, Demonstrates Safety, Efficacy, And Target Engagement In An 18-Month Phase 2b Trial (S27.008)
Evaluating safety, tolerability, and efficacy of PrimeC in people living with ALS (PwALS) through a randomized, placebo-controlled, double-blind Phase 2b trial (PARADIGM; NCT05357950); a 6-month double-blind phase (DB) followed by a 12-month open-label extension (OLE). Primary outcomes are safety, tolerability and key biomarkers, with ALS-progression and other ALS-related biomarkers as secondary and exploratory measures.
Authors
- Noam Shomron (ORCID: https://orcid.org/0000-0001-9913-6124)
- Ferenc Tracik
- Jeremy M. Shefner (ORCID: https://orcid.org/0000-0001-5067-5602)
- Ruben van Eijk
- Merit Cudkowicz (ORCID: https://orcid.org/0000-0002-7075-1681)
- Niva Russek‐Blum
- Guy Shapira (ORCID: https://orcid.org/0000-0001-9376-4955)
- Adriano Chiò (ORCID: https://orcid.org/0000-0001-9579-5341)
- Christian Lunetta (ORCID: https://orcid.org/0000-0002-4788-1875)
- Jeffrey Rosenfeld (ORCID: https://orcid.org/0000-0003-4327-7774)
- Vivian Drory
- Christen L. Shoesmith (ORCID: https://orcid.org/0000-0003-2472-3804)
- Shiran Zimri
- Diana Shtossel
Institutions
- Barrow Neurological Institute (US)
- Tel Aviv University (IL)
- Loma Linda University (US)
- Tel Aviv Sourasky Medical Center (IL)
- London Health Sciences Centre (CA)
- University Medical Center Utrecht (NL)
- Massachusetts General Hospital (US)
- Istituti Clinici Scientifici Maugeri (IT)
- University of Turin (IT)
Publication Details
- Journal
- Neurology
- Published
- 2025-04-07
- DOI
- https://doi.org/10.1212/wnl.0000000000211098
- Primary Topic
- Amyotrophic Lateral Sclerosis Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00