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.
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