REFALS
Research type
Research Study
Full title
Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS
IRAS ID
240367
Contact name
Ammar Al-Chalabi
Contact email
Sponsor organisation
Orion Corporation
Eudract number
2017-002754-36
Clinicaltrials.gov Identifier
134169, IND Number
Duration of Study in the UK
1 years, 10 months, 28 days
Research summary
Amyotrophic lateral sclerosis (ALS) is a rare, rapidly progressive neurological disease characterised by degeneration of upper and lower motor neurons with subsequent muscle atrophy (decrease in muscle mass) and weakness and loss of respiratory function. Median survival time from symptom onset is approximately 3 years. There are 3 medicines currently indicated for ALS, only one of which is licensed in Europe. There is an unmet need for new treatments in ALS.
Levosimendan (Simdax®) is currently approved in 60 countries, excluding the United Kingdom, as a medication given through a vein for heart failure. In this study the same substance will be tested for ALS given as a capsule (taken via the mouth). Levosimendan (ODM-109) is an investigational medicine (study medicine).
Studies have shown that levosimendan (ODM-109) may be useful to improve the muscle strength of the diaphragm and thereby the breathing function for patients with ALS. If ALS patients have increased breathing function, their overall well-being and function may also be increased.
The purpose of this research study is to measure how well and how safe levosimendan (ODM-109) is in treating patients with ALS.
Approximately 450 participants will take part in this research study. Participation will last approximately 1 year (51-52 weeks) including 10 study visits at the clinic (including screening and end of study visit) and 3 phone calls.
In this study, each group will receive either the study medicine levosimendan (ODM-109) or placebo (dummy medication). The chances of the participant receiving levosimendan (ODM-109) are 2:1 (67% chance to receive study medicine and 33% chance to receive placebo).
Procedures include: Physical examination, weight, height and body mass index, blood pressure, heart rate, electrocardiogram (recording of the heart), blood and urine samples, breathing function, swallow test, questionnaires, evaluations, questions about health status, diary including assistive devices and home care/health care support.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/0355
Date of REC Opinion
4 May 2018
REC opinion
Further Information Favourable Opinion