A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)
Condition(s) studied
Investigational drug(s) / intervention(s)
VHB937: VHB937 solution for infusion
Placebo: Solution for infusion
Study summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early-stage ALS (within 2 years of ALS symptoms onset). The study comprises a core double-blind (DB) 40-week treatment period followed by an open label extension (OLE).
Eligibility
Primary outcome measure(s)
- The composite of PAV-free survival and change in ALSFRS-R. Analysis method: Combined Assessment of Function and Survival (CAFS) — Baseline to DB Week 40
To compare the efficacy of VHB937 vs. placebo on a composite of permanent assisted ventilation (PAV) free survival and function in DB epoch
Trial sites (74)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California San Diego | La Jolla | California | |
| Loma Linda University Health | Loma Linda | California | |
| Keck Medical Center USC | Los Angeles | California | |
| UC San Francisco Medical Center | San Francisco | California | |
| University of Miami | Miami | Florida | |
| Orlando Health Clinical Trials | Orlando | Florida | |
| Emory University School of Medicine | Atlanta | Georgia | |
| University Of Kansas Medical Center | Kansas City | Kansas | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| University of Nebraska Medical Center | Omaha | Nebraska | |
| Lange Neurology PC | New York | New York | |
| University of Rochester Medical Center | Rochester | New York | |
| Atrium Health | Charlotte | North Carolina | |
| Duke University Health System | Durham | North Carolina | |
| Univ of Cincinnati Medical Center | Cincinnati | Ohio | |
| The Ohio State University | Columbus | Ohio | |
| Temple University | Philadelphia | Pennsylvania | |
| AMR Knoxville | Knoxville | Tennessee | |
| Austin Neuromuscular Center | Austin | Texas | |
| Nerve and Muscle Center of Texas | Houston | Texas | |
| University of Washington Medical Center | Seattle | Washington | |
| Novartis Investigative Site | North Ryde | New South Wales | |
| Novartis Investigative Site | Herston | Queensland | |
| Novartis Investigative Site | Caulfield South | Victoria | |
| Novartis Investigative Site | Southport | Australia | |
| Novartis Investigative Site | Leuven | Vlaams Brabant | |
| Novartis Investigative Site | Liège | Belgium | |
| Novartis Investigative Site | Calgary | Alberta | |
| Novartis Investigative Site | Montreal | Quebec | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Aalborg | Denmark | |
| Novartis Investigative Site | Kobenhavn N V | Denmark | |
| Novartis Investigative Site | Bron | France | |
| Novartis Investigative Site | Lille | France | |
| Novartis Investigative Site | Nice | France | |
| Novartis Investigative Site | Paris | France | |
| Novartis Investigative Site | Tours | France | |
| Novartis Investigative Site | Mannheim | Baden-Wurttemberg | |
| Novartis Investigative Site | Munich | Bavaria | |
| Novartis Investigative Site | Würzburg | Bavaria |
+ 34 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06643481 on ClinicalTrials.gov ↗ ← All trials in France