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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948178
Recruitment Status : Active, not recruiting
First Posted : May 13, 2019
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Levosimendan Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Levosimendan
Oral Levosimendan; Levosimendan 1mg capsules for oral administration, once to twice a day, continued as long as clinically beneficial. The total study duration is up to 3 years.
 Drug: Levosimendan
Levosimendan 1 mg capsule for oral administration
Other Name: ODM-109


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events Recording [ Time Frame: from Baseline through study completion, a maximum of 3 years ]
    Adverse Events as event counts, subject counts and proportions (%) of subject per AE

  2. Pulse/heart rate Assessment [ Time Frame: from Baseline through study completion, a maximum of 3 years ]
    Changes in pulse/heart rate values

  3. 12-lead electrocardiogram Assessments [ Time Frame: from Baseline through study completion, a maximum of 3 years ]
    Summarisation of any abnormal 12-lead ECG findings


Secondary Outcome Measures :
  1. Disease progression [ Time Frame: Baseline through study completion, a maximum of 3 years ]
    Count of study withdrawal due to disease progression

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

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

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

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

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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948178


Locations
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Spain
Hospital Universitari de Bellvitge
Barcelona, Spain, 08207
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Study Director: Geneviève Nadeau, CSD Orion Corporation, Orion Pharma
More Information
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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03948178    
Other Study ID Numbers: 3119003
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
 Simendan
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs