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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

Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date September 21, 2020
Actual Study Start Date  ICMJE June 26, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • 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
  • Pulse/heart rate Assessment [ Time Frame: from Baseline through study completion, a maximum of 3 years ]
    Changes in pulse/heart rate values
  • 12-lead electrocardiogram Assessments [ Time Frame: from Baseline through study completion, a maximum of 3 years ]
    Summarisation of any abnormal 12-lead ECG findings
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Disease progression [ Time Frame: Baseline through study completion, a maximum of 3 years ]
    Count of study withdrawal due to disease progression
  • Slow Vital Capacity (SVC) [ Time Frame: Baseline through study completion, a maxium of 3 years ]
    Pulmonary function assessment
  • Revised ALS Functional Rating Scale (ALSFRS-R) [ Time Frame: Baseline through study completion, a maximum of 3 years ]
    Scale
  • Need for Respiratory Support Device [ Time Frame: Baseline through study completion, a maximum of 3 years ]
    Questionnaire
  • Borg Category Ratio 10 Scale (CR 10) [ Time Frame: Baseline through study completion, a maximum of 3 years ]
    Scale
  • Health care and home care resource use [ Time Frame: Baseline through study completion, a maximum of 3 years ]
    Questionnaire
  • Subject's status for tracheostomy and survival [ Time Frame: Baseline through study completion, a maximum of 3 years ]
    Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label Extension
Official Title  ICMJE Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Drug: Levosimendan
Levosimendan 1 mg capsule for oral administration
Other Name: ODM-109
Study Arms  ICMJE 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.
Intervention: Drug: Levosimendan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948178
Other Study ID Numbers  ICMJE 3119003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orion Corporation, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Geneviève Nadeau, CSD Orion Corporation, Orion Pharma
PRS Account Orion Corporation, Orion Pharma
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP