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Quick Info
Status
Ongoing, But Not 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
Spain, Other
Hospital Universitari de Bellvitge, Barcelona, 08207, Spain
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
No longer recruiting, contact info changed
9/21/2020
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
Inclusion Criteria: - Written or verbal informed consent (IC) for participation in the study - Subjects who completed 48 weeks of treatment according to the REFALS study protocol - Able to swallow study treatment capsules at the time of completing 48 weeks dosing in the REFALS study Exclusion Criteria: - Development (or significant worsening from baseline of the REFALS study) of serious cardiovascular disease (e.g.: myocardial infarction, heart failure, arrhythmia, stroke, or second or third degree atrioventricular (AV) block) - Pulse/heart rate repeatedly >100 bpm after 5-minute rest at baseline. If the pulse/heart rate is >100 bpm in the first recording, then a second recording must be done after another 5 min rest to confirm pulse/heart rate >100 bpm - Systolic blood pressure (SBP) <90 mmHg - Severe renal impairment (creatinine clearance 170 µmol/l at 48 week visit of the REFALS study, or on dialysis - Severe hepatic impairment at the discretion of the investigator - Women of reproductive age without a negative pregnancy test and without a commitment to using a highly effective method of contraception (e.g.: oral hormonal contraceptive associated with inhibition of ovulation, intrauterine devices and long acting progestin agent), if sexually active during the study, and for 1 month after the last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included - Subject judged to be actively suicidal by the investigator - Any other clinical significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if he/she took part in the study
Details
Collaborator(s)
  • Orion Corporation, Orion Pharma
Trial Protocol as Published on Clinicaltrials.gov
NCT03948178 (First Published: 5/7/2019)