Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label Extension

Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label Extension

Quick Info:

Status:
Not Yet Recruiting
Estimated Enrollment:
450
Phase:
3
Treatment Type:
Drug: Levosimendan
Trial Type:
Single Group Assignment, Open-label
Sponsor:
Orion Corporation, Orion Pharma
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
N/A
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
N/A
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
N/A
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
N/A
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

5/13/2019Trial added

Locations:

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:
ALS Forum:
First Published on Clinicaltrials.gov: 5/13/2019
ClinicalTrials.gov ID: NCT03948178
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov