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

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

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:

9/6/2018Recruitment status updated
7/9/2018Now recruiting at more than 12 sites in 4 countries.
4/20/2018Trial added

Locations:

Academisch Medisch Centrum, Amsterdam, 1105 AZ
Alberta Health Services - Neuromuscular Clinic, Calgary, T3M1M4
Algemeen Ziekenhuis St. Lucas Gent, Gent
Allegheny General Hospital, Pittsburgh, 15212
Azienda Ospedaliera - Universitaria Città della Sa, Torino, 10126
Barts Health NHS Trust, London, E1 1BB
Beaumont Hospital - Ireland, Dublin
Brain and Mind Centre, Camperdpwn, 2050
Calvary Health Care Bethlehem, Caulfield, 3162
Centralsjukhuset Karlstad, Karlstad, 651 85
Centre Hospitalier Régional de la Citadelle, Liège
Charité Universitätsmedizin Berlin - Campus Vircho, Berlin, 13353
Colorado Springs Neurological Associates, Colorado Springs, 80907
Deutsche Klinik für Diagnostik, Wiesbaden, 65191
Duke University Medical Center, Durham, 27705
E1C 2Z3, Toronto, M4N 3M5
Emory University School of Medicine, Atlanta, 30322
Etelä-Karjalan keskussairaala, Lappeenranta, 53130
Flinders Medical Centre, Bedford Park, 5042
Froedtert Hospital, Milwaukee, 53226
HealthPartners Specialty Center, Saint Paul, 55130
Hopital Notre-Dame, Montreal, H2L 4M1
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
Hospital for Special Care, New Britain, 06053
Hospital of the University of Pennsylvania, Philadelphia, 19107
Kentucky Neuroscience Research, Louisville, 40202
King's College Hospital NHS Foundation Trust, London, SE5 9RS
Massachusetts General Hospital, Boston, 02114
Mayo Clinic - Jacksonville, Jacksonville, 32224
Mayo Clinic - Rochester, Rochester, 55905
Moncton Hospital, Southeast Regional Health Author, Moncton, E1C 2Z3
Montreal Neurological Institute and Hospital, Montréal, H3A 2B4
Nerve & Muscle Center of Texas, Houston, 77030
Neurologian Poliklinikka - Meilahden Tornisairaala, Helsinki, 00029
Neurology Associates, Lincoln, 68506
Neuromuscular Research Center and Neuromuscular Cl, Phoenix, 85028
Neurosciences Institute - Neurology Charlotte, Charlotte, 28207
Northwestern University Feinberg School of Medicin, Chicago, 60611
Perron Institute for Neurological and Translationa, Murdoch, 6150
Phoenix Neurological Associates, Phoenix, 85006
Providence Brain and Spine Institute, Portland, 97213
Providence Holy Cross Medical Center, Fort Lauderdale, 32209
Royal Brisbane and Women's Hospital, Brisbane, 4029
Salzkammergut-Klinikum Vöcklabruck, Vöcklabruck
Stan Cassidy Centre for Rehabilitation, Fredericton, E3B 0C7
Swedish Neuroscience Institute, Seattle, 98122
Texas Neurology, Dallas, 75214
The George Washington Medical Faculty Associates -, Washington, 20037
The Johns Hopkins Hospital, Baltimore, 21205
The Ohio State University, Columbus, 43210
The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ
Turku University Hospital, Turku, 20521
Universitair Medisch Centrum Utrecht - Rudolf Magn, Utrecht, 3584 CG
Universitaire Ziekenhuis Leuven, Leuven, 3000
University of Alberta, Edmonton
University of California San Diego, La Jolla, 92037-0886
University of Florida Health - Jacksonville, Jacksonville, 32209
University of Kentucky Chandler Medical Center, Lexington, 40536
University of Pittsburgh Medical Center, Pittsburgh, 15213
University of South Florida, Tampa, 33612
University of Utah - Imaging & Neurosciences Cente, Salt Lake City, 84108
Universität Innsbruck, Innsbruck, 6020
Universitätsklinikum Carl Gustav Carus, Dresden, 01307
Universitätsklinikum Jena, Jena, 07747
Universitätsklinikum Münster, Münster, 48149
Wake Forest University Baptist Medical Center, Winston-Salem, 27157
Washington University School of Medicine, St. Louis, 63110

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