ALS Progressive neurodegenerative disease
Conditions
Interventions
Test product will be Levosimendan 1 mg capsules
administered orally. The target maintenance dose of oral levosimendan will be 2
mg/day taken as 1 mg b.i.d.
Levosimendan treatment will be started at 1
Sponsors
Orion Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Written or verbal IC for participation in the study will be obtained from the patient. In case that the study patient him/herself cannot sign the IC, a witness may sign the consent form to indicate that the patient has given verbal consent. -The patient 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
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) 170 *mol/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 contraceptives associated with inhibition of ovulation, intrauterine devices and long acting progestin agents), 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. -Patient judged to be actively suicidal by the investigator. -Any other clinically 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: The primary objective, in addition to continuing treatment for subjects in REFALS study, is to evaluate long-term safety of oral levosimendan in amyotrophic lateral sclerosis (ALS) patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: The secondary objective is to explore long-term effectiveness of oral levosimendan in the treatment of patients with ALS, by continuing to observe rate of disease progression during the treatment. | — |
Countries
Netherlands
Outcome results
None listed