LEVALS
Research type
Research Study
Full title
Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension
IRAS ID
177109
Contact name
Ammar Al-Chalabi
Contact email
Sponsor organisation
Orion Corporation Orion Pharma
Eudract number
2014-004567-21
Duration of Study in the UK
1 years, 4 months, 16 days
Research summary
Amyotrophic Lateral Sclerosis, ALS, is a disease of the nerve cells in the brain and spinal cord that control voluntary muscle movement. Riluzole is the only approved medication for the treatment of ALS prolonging survival or time to tracheostomy by approximately 2-3 months. Levosimendan has been shown to increase skeletal muscle force and endurance as well as human diaphragm function. Hence, Levosimendan may be useful in the treatment for ALS.
The primary objective of this study will investigate the effect of oral levosimendan on the respiratory function of patients with Amyotrophic Lateral Sclerosis. The study will also evaluate for effect oral levosimendan on the patient's hand grip strength, hand grip endurance as well as the patient's quality of life and daily functions.
The study will also collect data on safety and tolerability of the IMP.
The study will evaluate the concentrations of the IMP, and the substances that the human body naturally forms to metabolize the IMP (metabolites), in the blood stream, and how the presence of these naturally formed metabolites impact on study endpoints.
The study will also examine the effects of the IMP on Riluzole. All enrolled patients are required to be on a stable Riluzole dose at the time of enrolment and will be required to continue taking Riluzole for the duration of their participation in the study.
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/0684
Date of REC Opinion
27 May 2015
REC opinion
Further Information Favourable Opinion