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Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002 (REFALS-ES)

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase III

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT03948178

Neals Affiliated?

No

Coordinating Center Contact Information

Massachusetts General Hospital
Merit E Cudkowicz, MD / .(JavaScript must be enabled to view this email address) / 617-726-2383
.(JavaScript must be enabled to view this email address) Boston, Massachusetts United States

Full Study Summary:

Study Sponsor:

Orion Corporation, Orion Pharma

Participant Duration:

Estimated Enrollment:

450

Estimated Study Start Date:

06/26/2019

Estimated Study Completion Date:

07/31/2022

Posting Last Modified Date:

09/16/2019

Date Study Added to alsconsortium.org:

09/16/2019

Eligibility Criteria

Gender:
Female, Male
Minimum Age:
N/A
Maximum Age:
N/A

Time since Symptom Onset:

Time since Diagnosis:

Can participants use Riluzole?
Yes

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
Site Contact Information

Hospital Universitari de Bellvitge
Barcelona, 08207
Spain