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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT03948178
• Date of registration: 07/05/2019
• Prospective Registration: Yes
• Primary sponsor: Orion Corporation, Orion Pharma
• Public title: Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label Extension REFALS-ES
• Scientific title: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002
• Date of first enrolment: June 26, 2019
• Target sample size: 227
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03948178
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Spain

Contacts

• Name: Geneviève Nadeau, CSD
• Affiliation: Orion Corporation, Orion Pharma

Key inclusion & exclusion criteria

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 < 30ml/min or creatine >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



Age minimum: 18 Years
Age maximum: 120 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Levosimendan

Primary Outcome(s)

Adverse Events Recording [Time Frame: from Baseline through study completion, a maximum of 3 years]

Pulse/heart rate Assessment [Time Frame: from Baseline through study completion, a maximum of 3 years]

12-lead electrocardiogram Assessments [Time Frame: from Baseline through study completion, a maximum of 3 years]

Secondary Outcome(s)

Need for Respiratory Support Device [Time Frame: Baseline through study completion, a maximum of 3 years]

Disease progression [Time Frame: Baseline through study completion, a maximum of 3 years]

Health care and home care resource use [Time Frame: Baseline through study completion, a maximum of 3 years]

Subject's status for tracheostomy and survival [Time Frame: Baseline through study completion, a maximum of 3 years]

Borg Category Ratio 10 Scale (CR 10) [Time Frame: Baseline through study completion, a maximum of 3 years]

Revised ALS Functional Rating Scale (ALSFRS-R) [Time Frame: Baseline through study completion, a maximum of 3 years]

Slow Vital Capacity (SVC) [Time Frame: Baseline through study completion, a maxium of 3 years]

Secondary ID(s)

3119003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors