Quick Info
Status
Not Yet Recruiting
Estimated Enrollment
450
Phase
3
Treatment Type
Drug: Levosimendan
Trial Type
Single Group Assignment, Open-label
Primary Investigator
Geneviève Nadeau, CSD
Contact Information
Locations
Hospital Universitari de Bellvitge, Barcelona, 08207
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
N/A
Months Since Onset
Number of months since first symptoms of ALS.
N/A
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
N/A
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
N/A
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Update Notes
Updated Location Recruiting
8/30/2019
Trial added
5/13/2019

Other Information

Purpose
This study provides an opportunity for subjects in the REFALS (3119002; NCT03505021) study to continue treatment with oral levosimendan. The study will also provide more information about long-term safety and effectiveness of oral levosimendan in patients with ALS. This is an open-label study, so that all eligible subjects that complete the double-blind REFALS study (48-weeks of treatment) will have the opportunity to receive oral levosimendan treatment. The primary objective, in addition to continuing treatment for subjects enrolled in the REFALS study, is to evaluate long-term safety of oral levosimendan in ALS patients. Another important objective is to explore long-term effectiveness of oral levosimendan in the treatment of patients with ALS. This study is open only to patients taking part in the REFALS study.
Eligibility
18 Years to 120 Years, all genders, not accepting healthy volunteers, must have completed REFALS study
Details
Collaborator(s)
    -
News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT03948178 (First Published: 5/13/2019)
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