Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS (REFALS)

Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS (REFALS)

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
450
Phase:
3
Treatment Type:
Drug: Levosimendan
Trial Type:
Randomized, parallel assignment, Quadruple masking
Sponsor:
Orion Corporation, Orion Pharma
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
SVC between 60-90%
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
12-48 months
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
no
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
no
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Yes

Update Notes:

2/11/2019No significant updates
1/18/2019No significant updates
1/7/2019Location updated
12/13/2018Recruitment status updated
9/6/2018Recruitment status updated
7/9/2018Now recruiting at more than 12 sites in 4 countries.
4/20/2018Trial added

Locations:

Neuromuscular Research Center and Neuromuscular Cl, Phoenix, 85028
Phoenix Neurological Associates, Phoenix, 85006
University of California San Diego, La Jolla, 92037-0886
Cedars-Sinai Medical Center, Los Angeles, 90048
University of California Irvine, Orange, 92868
California Pacific Medical Center, San Francisco, 94115
Colorado Springs Neurological Associates, Colorado Springs, 80907
Hospital for Special Care, New Britain, 06053
The George Washington Medical Faculty Associates -, Washington, 20037
Georgetown University, Washington, 20007
Mayo Clinic - Jacksonville, Jacksonville, 32224
Providence Holy Cross Medical Center, Fort Lauderdale, 32209
University of Florida Health - Jacksonville, Jacksonville, 32209
University of South Florida, Tampa, 33612
University of Florida, Gainsville, 32611
Emory University School of Medicine, Atlanta, 30322
Augusta University, Augusta, 30912
Northwestern University Feinberg School of Medicin, Chicago, 60611
Kentucky Neuroscience Research, Louisville, 40202
University of Kentucky Chandler Medical Center, Lexington, 40536
Massachusetts General Hospital, Boston, 02114
The Johns Hopkins Hospital, Baltimore, 21205
University of Michigan, Ann Arbor, 49007
HealthPartners Specialty Center, Saint Paul, 55130
Mayo Clinic - Rochester, Rochester, 55905
Washington University School of Medicine, St. Louis, 63110
Duke University Medical Center, Durham, 27705
Neurosciences Institute - Neurology Charlotte, Charlotte, 28207
Wake Forest University Baptist Medical Center, Winston-Salem, 27157
Neurology Associates, Lincoln, 68506
Mount Sinai Beth Israel, New York, 10003
Hospital for Special Surgery, New York, 10021
Columbia Presbyterian Hospital, New York, 10032
The Ohio State University, Columbus, 43210
Providence Brain and Spine Institute, Portland, 97213
Oregon Health and Science University, Portland, 97201
Allegheny General Hospital, Pittsburgh, 15212
Hospital of the University of Pennsylvania, Philadelphia, 19107
University of Pittsburgh Medical Center, Pittsburgh, 15213
Nerve & Muscle Center of Texas, Houston, 77030
Texas Neurology, Dallas, 75214
University of Utah - Imaging & Neurosciences Cente, Salt Lake City, 84108
University of Vermont Medical Center, Burlington, 05401
Swedish Neuroscience Institute, Seattle, 98122
University of Washington Medical Center, Seattle, 98195
Froedtert Hospital, Milwaukee, 53226
Barts Health NHS Trust, London, E1 1BB
King's College Hospital NHS Foundation Trust, London, SE5 9RS
The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ
Centralsjukhuset Karlstad, Karlstad, 651 85
Academisch Medisch Centrum, Amsterdam, 1105 AZ
Universitair Medisch Centrum Utrecht - Rudolf Magn, Utrecht, 3584 CG
Azienda Ospedaliera - Universitaria Città della Sa, Torino, 10126
Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara, Novara, 28100
ICS Maugeri Spa SB, Pavia, 27100
Azienda Ospedaliero-Universitaria Pisana Santa Chiara, Pisa, 56126
Policlinico Umberto I di Roma, Roma, 0016
Beaumont Hospital - Ireland, Dublin
Etelä-Karjalan keskussairaala, Lappeenranta, 53130
Neurologian Poliklinikka - Meilahden Tornisairaala, Helsinki, 00029
Turku University Hospital, Turku, 20521
Hospital San Rafael - Madrid, Madrid
Hospital Universitari de Bellvitge, Barcelona, 08207
Hospital Universitario Reina Sofia, Córdoba, 14011
Hospital Universitario y Politécnico de La Fe, Valencia, 46026
Hospital de Basurto, Bilboa, 48013
Charité Universitätsmedizin Berlin - Campus Vircho, Berlin, 13353
Deutsche Klinik für Diagnostik, Wiesbaden, 65191
Universitätsklinikum Carl Gustav Carus, Dresden, 01307
Universitätsklinikum Jena, Jena, 07747
Universitätsklinikum Münster, Münster, 48149
Universitätsklinikum Ulm, Ulm, Baden-Württemberg, 89081
Alberta Health Services - Neuromuscular Clinic, Calgary, T3M1M4
University of Alberta, Edmonton
Moncton Hospital, Southeast Regional Health Author, Moncton, E1C 2Z3
Stan Cassidy Centre for Rehabilitation, Fredericton, E3B 0C7
E1C 2Z3, Toronto, M4N 3M5
Hopital Notre-Dame, Montreal, H2L 4M1
Montreal Neurological Institute and Hospital, Montréal, H3A 2B4
Centre Hospitalier Affilie Universitaire de Quebec, Québec, G1J 1Z4
Algemeen Ziekenhuis St. Lucas Gent, Gent
Centre Hospitalier Régional de la Citadelle, Liège
Universitaire Ziekenhuis Leuven, Leuven, 3000
Brain and Mind Centre, Camperdpwn, 2050
Calvary Health Care Bethlehem, Caulfield, 3162
Flinders Medical Centre, Bedford Park, 5042
Perron Institute for Neurological and Translationa, Murdoch, 6150
Royal Brisbane and Women's Hospital, Brisbane, 4029
Salzkammergut-Klinikum Vöcklabruck, Vöcklabruck
Universität Innsbruck, Innsbruck, 6020
Medizinische Universität Wien, Wien, 1090
Alfried Krupp Krankenhaus Rüttenscheid, Essen, Nordrhein-westfalen, 45131

Other Information:

Purpose: In the randomized, double-blind, placebo-controlled, parallel-group, multicentre study, ODM-109 capsules and placebo capsules for ODM-109 is administered for 48 weeks. The subjects are allocated to 2 parallel groups receiving either levosimendan 1-2 mg daily or placebo in 2:1 ratio. There is a screening visit, a baseline visit followed by visits at 2, 4, 8, 12, 24, 36 and 48 weeks, and telephone contacts during weeks 18, 30 and 42. An end-of-study visit takes place 14-25 days after the last study treatment administration for each subject. The total study duration for each subject is about 51-52 weeks including the end-of-study visit. The planned number of study subjects is approximately 450. Primary objective is to confirm that levosimendan can significantly improve respiratory function in patients with amyotrophic lateral sclerosis (ALS).
Eligibility: 18 to 120 years, all genders, not accepting healthy volunteers
Details:
Collaborator(s):
News Articles and Summaries:
ALS Forum: View Forum Link
First Published on Clinicaltrials.gov: 4/16/2018
ClinicalTrials.gov ID: NCT03505021
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov