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Oral Levosimendan Open-Label Extension in ALS
NCT03948178Phase 3
Key facts
- Status
- Terminated
- Start
- Jun 2019
- Primary completion
- Nov 2020
- Countries
- 14
- Sponsor
- Orion Corporation
- Modality
- Small Molecules
- Drugs
- levosimendan
- Conditions
- amyotrophic lateral sclerosis (ALS)
01
Overview
Phase 3, open-label, single-arm trial of levosimendan in amyotrophic lateral sclerosis (ALS), sponsored by Orion Corporation. Primary endpoints: Adverse Events Recording, Pulse/Heart Rate Assessment and 1 more. Started Jun 2019; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Levosimendan
Oral Levosimendan 1mg capsules
03
Who it enrols
Patients who completed the 48-week double-blind REFALS study, are able to swallow capsules, and do not have severe cardiovascular, renal, or hepatic impairment.
04
Endpoints
Primary
Adverse Events Recording
Pulse/Heart Rate Assessment
12-lead Electrocardiogram Assessments
Secondary
Disease Progression
Supine Slow Vital Capacity
Revised ALS Functional Rating Scale
Need for Respiratory Support Device
Borg Category Ratio 10 Scale
Number of Subjects Requiring Health and Home Care Resource Use
Subject's Status for Tracheostomy and Survival
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