Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS

Phase 3

Completed

• Conditions: ALS; 10029317; Progressive neurodegenerative disease

• Registration Number: NL-OMON50701
• Lead Sponsor: Orion Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

Male or female subjects with diagnosis of ALS, disease duration from symptom
onset of 12-48 months, written or verbal informed consent (IC) obtained from
the subject. Age at least 18 years. Able to swallow study treatment capsules,
and in the opinion of the investigator, is expected to continue to do so during
the study. Sitting SVC between 60-90% of the predicted value for age, height
and sex at screening visit. Able to perform supine SVC at screening and
baseline visits.
Subjects with or without riluzole. If using riluzole (any daily dose up to
100 mg), the dose must have been stable for at least 4 weeks before the
screening visit and
should not be changed during the study. If not on riluzole,
the respective treatments should not be started during the study.

Exclusion Criteria

Subject in whom other causes of neuromuscular weakness have not been excluded.
Subject with a diagnosis of another neurodegenerative disease (e.g. Parkinson*s
or Alzheimer*s disease).
Assisted ventilation of any type within 3 months before the screening visit or
at screening.
Any use of a diaphragm pacing system (DPS) within 3 months before the screening
visit.
Any form of stem cell or gene therapy for the treatment of ALS.
Known hypersensitivity to levosimendan.
Administration of levosimendan within 3 months before the screening visit or
previous participation in the present phase III study or earlier study with
oral levosimendan in ALS patients (LEVALS).
Any use of tirasemtiv or reldesemtiv within 1 month before the screening visit.
Participation in a clinical trial with any experimental treatment within 30
days or within 5 half-lives of that treatment (whichever is longer) before the
screening visit.
Any botulinum toxin use within 3 months before the screening visit.
Recorded diagnosis or evidence of major psychiatric diagnosis, significant
cognitive impairment or clinically evident dementia that may interfere with the
patient*s ability to comply with study procedures.
Pulmonary illness (e.g. asthma or COPD) requiring regular treatment.
Haemodynamically significant uncorrected valve disease or hypertrophic
cardiomyopathy or restrictive cardiomyopathy.
Any cardiovascular event (e.g. myocardial infarction, HF, arrhythmia or stroke)
requiring hospitalisation within 3 months before the screening visit.
History of Torsades de Pointes (TdP) or diagnosed long QT-syndrome.
History of life-threatening ventricular arrhythmia, unless treated with
reliable measures to prevent recurrence (e.g. with placement of implantable
cardioverter defibrillator [ICD] or catheter ablation).
History of second or third degree atrioventricular (AV) block or sinus node
disease at screening, if not treated with pacemaker.
HR repeatedly > 100 bpm in the 12-lead ECG after a 5-minute rest at screening.
If the HR is > 100 bpm in the first recording, then the second recording must
be done after another 5 min rest to confirm HR > 100 bpm.
Systolic blood pressure (SBP) < 90 mmHg at screening.
Potassium < 3.7 mmol/l or > 5.5 mmol/l at screening.
Several renal impairment (creatinine clearance < 30 ml/min at screening),
creatinine > 170 *mol/l at screening or on dialysis.
Blood haemoglobin < 10 g/dl at screening or blood donation or loss of
significant amount of blood within 60 days before the screening visit.
Clinically significant hepatic impairment at the discretion of the investigator.
Body mass index (BMI) * 18.5kg/m2 (BMI = weight/height2).
Women who are lactating or 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 during 3 months
before the scre

Study & Design

• Study Type: Interventional
• Study Design: Not specified