Eine Phase 3, multizentrische, doppelblinde, randomisierte, Plazebo-kontrollierte Studie zur Beurteilung der Wirksamkeit und Sicherheit von Reldesemtiv bei Patienten mit Amyotropher Lateralsklerose (ALS)

Project

Eine Phase 3, multizentrische, doppelblinde, randomisierte, Plazebo-kontrollierte Studie zur Beurteilung der Wirksamkeit und Sicherheit von Reldesemtiv bei Patienten mit Amyotropher Lateralsklerose (ALS)

Automatically Closed · 2022 until 2023

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Status

Automatically Closed

Start Date

2022

End Date

2023

Financing

Industry

Keywords

ALS, Muskelzellaktivator, randomisiert, placebo-kontrolliert

Brief description/objective

Reldesemtiv, a fast skeletal muscle troponin activator (FSTA), is being investigated as a potential therapy to slow the decline of skeletal muscle function in patients with ALS. This pivotal trial with reldesemtiv is being conducted in ALS patients and is designed to assess the effect of reldesemtiv on functional outcomes during treatment up to 48 weeks. The first trial with reldesemtiv in ALS patients (FORTITUDE-ALS [CY 5022]) after 12 weeks of dosing, showed that patients on all doses of reldesemtiv tended to decline less than patients on placebo for slow vital capacity (SVC) and ALS Functional Rating Scale-Revised (ALSFRS-R), with larger and clinically meaningful differences emerging over time. The results support progression in a further clinical trial with a longer dosing duration.