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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03505021
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief Summary:
This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Levosimendan Drug: Placebo for levosimendan Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : October 30, 2020


Arm Intervention/treatment
Experimental: Levosimendan
Levosimendan 1 mg capsules for oral administration, once to twice a day. The total duration of treatment 48 weeks
Drug: Levosimendan
Levosimendan 1 mg capsule for oral administration
Other Name: ODM-109

Placebo Comparator: Placebo for levosimendan
Placebo capsule for oral administration, once to twice a day. The total duration of treatment 48 weeks.
Drug: Placebo for levosimendan
Placebo capsule for oral administration
Other Name: Placebo for ODM-109




Primary Outcome Measures :
  1. Supine slow vital capacity SVC [ Time Frame: the change from baseline at 12 weeks ]
    Pulmonary assessment


Secondary Outcome Measures :
  1. Combined assessment of Revised ALS Functional Rating Scale ALSFRS-R function and survival through 48 weeks [ Time Frame: the change from baseline at 48 weeks ]
    Scale

  2. Time to respiratory event through 48 weeks [ Time Frame: the change from baseline at 48 weeks ]
    Pulmonary assessment, scale

  3. Clinical Global Impression CGI at 48 weeks [ Time Frame: the change from baseline at 48 weeks ]
    Scale

  4. Change from baseline in respiratory function of ALSFRS-R at 48 weeks [ Time Frame: the change from baseline at 48 weeks ]
    Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written or verbal informed consent (IC) for participation in the study
  • Male or female subjects with diagnosis of laboratory supported probable, probable or definite ALS according to El Escorial revised criteria. Full electromyogram (EMG) report available consistent with ALS (but not necessarily fulfilling the electrodiagnostic criteria for ALS) from an experienced neurophysiologist
  • Able to swallow study treatment capsules, and in the opinion of the investigator, is expected to continue to do so during the study
  • Sitting SVC between 60-90% of the predicted value for age, height and sex at screening visit
  • Disease duration from symptom onset (defined by first muscle weakness or dysarthria) 12-48 months at the time of visit 1 (baseline)
  • Able to perform supine SVC in an adequate and reliable way at screening and baseline visits as judged by the investigator
  • Subjects with or without riluzole and/or edaravone. If using riluzole (any daily dose up to 100 mg), the dose must have been stable for at least 4 weeks before the screening visit and should not be changed during the study. If using edaravone, the treatment should have been started at least 4 weeks before the screening visit (at least one 28-day treatment cycle as indicated) and should not be changed during the study. If not on riluzole and/or edaravone, the respective treatments should not be started during the study

Exclusion Criteria:

  • Subject in whom other causes of neuromuscular weakness have not been excluded
  • Subject with a diagnosis of another neurodegenerative disease (e.g. Parkinson's or Alzheimer's disease)
  • Assisted ventilation of any type within 3 months before the screening visit or at screening
  • Any use of a diaphragm pacing system (DPS) within 3 months before the screening visit
  • Any form of stem cell or gene therapy for the treatment of ALS
  • Known hypersensitivity to levosimendan
  • Administration of levosimendan within 3 months before the screening visit or previous participation in the present phase III study or earlier study with oral levosimendan in ALS patients (LEVALS)
  • Any use of tirasemtiv or reldesemtiv within 1 month before the screening visit.
  • Participation in a clinical trial with any experimental treatment within 30 days or within 5 half-lives of that treatment (whichever is longer) before the screening visit
  • Any botulinum toxin use within 3 months before the screening visit
  • Recorded diagnosis or evidence of major psychiatric diagnosis, significant cognitive impairment or clinically evident dementia that may interfere with the patient's ability to comply with study procedures
  • Pulmonary illness (e.g. asthma or COPD) requiring regular treatment
  • Haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy
  • Any cardiovascular event (e.g. myocardial infarction, HF, arrhythmia or stroke) requiring hospitalisation within 3 months before the screening visit
  • History of Torsades de Pointes (TdP) or diagnosed long QT-syndrome
  • History of life-threatening ventricular arrhythmia, unless treated with reliable measures to prevent recurrence (e.g. with placement of implantable cardioverter defibrillator [ICD] or catheter ablation)
  • History of second or third degree atrioventricular (AV) block or sinus node disease at screening, if not treated with pacemaker
  • HR repeatedly > 100 bpm in the 12-lead ECG after a 5-minute rest at screening. If the HR is > 100 bpm in the first recording, then the second recording must be done after another 5 min rest to confirm HR > 100 bpm
  • Systolic blood pressure (SBP) < 90 mmHg at screening
  • Potassium < 3.7 mmol/l or > 5.5 mmol/l at screening
  • Severe renal impairment (creatinine clearance < 30 ml/min at screening), creatinine > 170 μmol/l at screening or on dialysis
  • Blood haemoglobin < 10 g/dl at screening or blood donation or loss of significant amount of blood within 60 days before the screening visit
  • Clinically significant hepatic impairment at the discretion of the investigator
  • Body mass index (BMI) ≤ 18.5kg/m2 (BMI = weight/height2)
  • Women who are lactating or of reproductive age without a negative pregnancy test and without a commitment to using a highly effective method of contraception (e.g. oral hormonal contraceptives associated with inhibition of ovulation, intrauterine devices and long acting progestin agents), 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
  • Patient judged to be actively suicidal by the investigator during 3 months before the screening visit
  • Patients with known history of human immunodeficiency virus (HIV) infection
  • Any other clinically 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505021


Contacts
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Contact: Merit E Cudkowicz, MD +1 617 726 2383 Cudkowicz.Merit@mgh.harvard.edu
Contact: Merja Mäkitalo, CSD +358 50 9667737 merja.makitalo@orionpharma.com

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Locations
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United States, Arizona
Phoenix Neurological Associates Recruiting
Phoenix, Arizona, United States, 85006
Neuromuscular Research Center and Neuromuscular Clinic of Arizona Recruiting
Phoenix, Arizona, United States, 85028
Contact: Kumaraswamy Sivakumar, MD    480-314-1007    nrcresearch@nrcaz.com   
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92037-0886
Contact: Rose Previte       rprevite@ucsd.edu   
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Dana Fine    310-423-8497    dana.fine@cshs.org   
University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: Ivonne Turner    714-546-8323    imturner@uci.edu   
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
United States, Colorado
Colorado Springs Neurological Associates Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Lisa Deschaine    719-389-1129      
United States, Connecticut
Hospital for Special Care Recruiting
New Britain, Connecticut, United States, 06053
Contact: Honora Dalamagas, RN, MS    860-612-6356    hdalamagas@hfsc.org   
Contact: Stephanie Beck    1 (860) 827-1958 ext 5753    beckst@hfsc.org   
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Sasha Warren    202-444-6941      
The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion Recruiting
Washington, District of Columbia, United States, 20037
Contact: Lindsey Covington    202-741-2745    licovington@mfa.gwu.edu   
United States, Florida
Providence Holy Cross Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Lindita Burba    954-489-4314    lindita.burba@holy-cross.com   
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Jennifer Steshyn, MABMH, CCRP       jennifer.steshyn@neurology.ufl.edu   
University of Florida Health - Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Lisa Smith       lisa.smith@jax.ufl.edu   
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Bjorn Oskarsson         
Contact: Arijana Draganovic    1 (904) 953-6912    mayofloridaALSresearch@mayo.edu   
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Brittany Harvey    813-974-9413    bharvey1@health.usf.edu   
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jane Bordeau, RN       JrBord@emory.edu   
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Michael H. Rivner, M.D.       Mrivner@augusta.edu   
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Benjamin Joslin       ben.joslin@northwestern.edu   
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jacquelyn Hill       jhill@neurology.bsd.uchicago.edu   
United States, Kentucky
University of Kentucky Chandler Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Meha Joshi, BA    859-218-5046    majo235@uky.edu   
Kentucky Neuroscience Research Recruiting
Louisville, Kentucky, United States, 40202
Contact: Annette Robinson, RN,BSN,CCRC    502-540-3585    annette.robinson@louisville.edu   
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Kristen Riley       KRiley15@jhmi.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Olivia Pijanowski    617-643-2522    opijanowski@mgh.harvard.edu   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 49007
Contact: Jayna Duell    734-936-8776    jkballar@med.umich.edu   
United States, Minnesota
Mayo Clinic - Rochester Recruiting
Rochester, Minnesota, United States, 55905
HealthPartners Specialty Center Recruiting
Saint Paul, Minnesota, United States, 55130-5302
Contact: Gaurav Guliani    651-495-6363    clinicaltrials@healthPartners.com   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kelly Streckfuss       kstreckfuss@wustl.edu   
United States, Nebraska
Neurology Associates Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Ashley Calhoun, LPN    402-770-7403    Ashley@somnos.com   
United States, New York
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Contact: Stephen Scelsa, MD    212-844-8490    stephen.scelsa@mountsinai.org   
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Shara Holzberg    646-797-8592    holzbergs@hss.edu   
Columbia Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Jinsy Andrews, MD       ja2289@cumc.columbia.edu   
Contact: Meenakshi Rozenstrauch    1 (212) 305-2233    mr3823@cumc.columbia.edu   
United States, North Carolina
Neurosciences Institute - Neurology Charlotte Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Cynthia Lary, RN       cynthia.lary@atriumhealth.org   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Karen Grace, RN    919-668-2844    karen.grace@duke.edu   
Wake Forest University Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1023
Contact: James Caress, MD    336-713-8577      
Contact: Mozhdeh Marandi         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Adam Quick, Dr       adam.quick@osumc.edu   
Contact: Rory Eustace       rory.esutace@osumc.edu   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97201-3098
Contact: Anneka Sonstroem    503-494-7394    sonstroe@ohsu.edu   
Providence Brain and Spine Institute Recruiting
Portland, Oregon, United States, 97213
Contact: Arlena Cummings, CCRP    503-962-1171    arlena.cummings@providence.org   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kelly Almasy, RN, CRC    215-829-5041    kelly.almasy@uphs.upenn.edu   
Temple University School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Kathleen Hatala, RN, BSN    215-707-4171    kathleen.hatala@tuhs.temple.edu   
Contact: Theresa Ropars, RN, BSN    1 (215) 707-5440    Theresa.Ropars@tuhs.temple.edu   
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Sandeep Rana       sandeep.rana@ahn.org   
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Danielle Rowlands, MSN    412-864-2873    doerdx@upmc.edu   
United States, Texas
Texas Neurology Recruiting
Dallas, Texas, United States, 75214
Contact: Daragh Heitzman, MD    214-827-3610      
Nerve and Muscle Center of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Zinah Rasheed    713-795-0033    houneuzinah@msn.com   
United States, Utah
University of Utah - Imaging & Neurosciences Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Mark Bromberg    801-585-7575      
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Shannon Lucy    802-656-4582    shannon.lucy@med.uvm.edu   
United States, Washington
Swedish Neuroscience Institute Recruiting
Seattle, Washington, United States, 98122
Contact: Robin Smith    206-320-2334    robin.smith3@swedish.org   
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Laura Sissons-Ross    206-543-0081    lsissons@uw.edu   
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lynn Wheeler    414-805-9307    lwheeler@mcw.edu   
Australia, New South Wales
Brain and Mind Centre Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Eleanor Ramsey    02 9351 0976 or 029114 4250      
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Susan Heggie, RN    07 3646 8111    Susan.Heggie@health.qld.gov.au   
Australia, South Australia
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: David Schultz, Dr    61 8 8204 4187      
Australia, Victoria
Calvary Health Care Bethlehem Recruiting
Caulfield South, Victoria, Australia, 3162
Contact: Emma Windebank       Emma.Windebank@calvarycare.org.au   
Australia, Western Australia
Perron Institute for Neurological and Translational Science Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: Joanne Borrelli       joanne.borrelli@perron.uwa.edu.au   
Austria
Universität Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Wolfgang Löscher, Prof       wolfgang.loescher@i-med.ac.at   
Contact: Marina Peball, Dr    43-512-504-25810    marina.peball@i-med.ac.at   
Salzkammergut-Klinikum Vöcklabruck Recruiting
Vöcklabruck, Upper Austria, Austria, 4840
Medizinische Universität Wien Recruiting
Wien, Austria, 1090
Belgium
Universitaire Ziekenhuis Leuven Recruiting
Leuven, Flemish Brabant, Belgium, 3000
Contact: Philip Van Damme    016 344280      
Centre Hospitalier Régional de la Citadelle Recruiting
Liège, Liege, Belgium, 4000
Contact: Stephanie Delstanche, Dr    00 32 4 321 82 24    stephanie.delstanche@chrcitadelle.be   
Algemeen Ziekenhuis St. Lucas Gent Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Jan De Bleeker, Prof, Dr    32-9-2246530      
Canada, Alberta
Alberta Health Services - Neuromuscular Clinic Recruiting
Calgary, Alberta, Canada, T3M 1M4
Contact: Jose Martinez    1 (403) 210-7009    jamarti@ucalgary.ca   
Contact: Janet Petrillo    1 (403) 210-7006    japetril@ucalgary.ca   
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Wendy Johnston, Dr.    (780) 248-1089      
Contact: Kelsey Tymkow    (780) 248-1329      
Canada, New Brunswick
Stan Cassidy Centre for Rehabilitation Recruiting
Fredericton, New Brunswick, Canada, E3B 0C7
Contact: Colleen O'Connell, Dr.       drcolleenoconnell@horizonnb.ca   
Contact: Susan McCully       Susan.McCully@horizonnb.ca   
Moncton Hospital, Southeast Regional Health Authority Recruiting
Moncton, New Brunswick, Canada, E1C 2Z3
Contact: Cynthia Lary, RN       Recherche.research@vitalitenb.ca   
Canada, Ontario
McMaster University Medical Centre Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Daniela Trapsa       trapsd@mcmaster.ca   
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Adrienne Sulistyo    1 (416) 480-6100 ext 87561    adrienne.sulistyo@sri.utoronto.ca   
Canada, Quebec
Centre De Recherche Du Centre Hospitalier de l'Universite de Montreal - Hopital Notre-Dame Recruiting
Montréal, Quebec, Canada, H2L 4M1
Contact: Geneviève Matte, Dr.    1 (514) 890-8000 ext 27208      
Montreal Neurological Institute and Hospital Recruiting
Montréal, Quebec, Canada, H3A 2B4
Contact: Angela Genge, MD, FRCP    1 (514) 298-3868    angela.genge@mcgill.ca   
Contact: Natalie Saunders    1 (514) 398-6526    Natalie.Saunders@mcgill.ca   
Centre Hospitalier Affilie Universitaire de Quebec Recruiting
Québec, Quebec, Canada, G1J 1Z4
Contact: Alexandra Simard    1 (418) 649-0252      
Finland
Neurologian Poliklinikka - Meilahden Tornisairaala 3 Recruiting
Helsinki, Finland, 00029
Etelä-Karjalan keskussairaala Recruiting
Lappeenranta, Finland, 53130
Turku University Hospital Recruiting
Turku, Finland, 20521
France
Centre Hospitalier Universitaire de Limoges Recruiting
Limoges, France, 87042
Hôpital Gui de Chauliac Recruiting
Montpellier, France, 34295
Hôpital Pasteur Recruiting
Nice, France, 06202
Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau Recruiting
Tours, France, 37044
Germany
Universitätsklinikum Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact: A. C. Ludolph, Prof.       albert.ludolph@rku.de   
Deutsche Klinik für Diagnostik Recruiting
Wiesbaden, Hessen, Germany, 65191
Contact: Martina Müller    49 611-577652    martina.mueller4@helios-gesundheit.de   
Universitätsmedizin Rostock Recruiting
Rostock, Mecklenburg-western-pommerania, Germany, 18147
Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Susanne Petri, Prof.       petri.susanne@mh-hannover.de   
Alfried Krupp Krankenhaus Rüttenscheid Recruiting
Essen, Nordrhein-westfalen, Germany, 45131
Universitätsklinikum Münster Recruiting
Münster, Nordrhein-Westfalen, Germany, 48149
Contact: Matthias Boentert    +49 251-834-8196    matthias.boentert@ukmuenster.de   
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Andreas Hermann, Prof., Dr.         
Contact: R. Guenther, Dr.    493514582524      
Universitätsklinikum Jena Recruiting
Jena, Thuringen, Germany, 07747
Contact: Julian Großkreutz    4936419323428    julian.grosskreutz@med.uni-jena.de   
Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
Contact: Thomas Meyer, Prof., Dr.    0049 30 450 560 028      
Ireland
Beaumont Hospital - Ireland Recruiting
Dublin, Ireland, 9
Contact: Orla Hardiman       orla@hardiman.net   
Italy
Azienda Ospedaliera Universitaria San Martino Recruiting
Genova, Italy, 16132
Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara Recruiting
Novara, Italy, 28100
Contact: Latizia Mazzini       ambulatorioslanovara@tiscali.it   
ICS Maugeri Spa SB Recruiting
Pavia, Italy, 27100
Contact: Gabriele Mora       gabriele.mora@icsmaugeri.it   
Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara Recruiting
Pisa, Italy, 56126
Policlinico Umberto I di Roma Recruiting
Roma, Italy, 0016
Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino Recruiting
Torino, Italy, 10126
Contact: Adriano Chio    39 0116709170    adriano.chio@unito.it   
Netherlands
Academisch Medisch Centrum Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Marije Voermans    20 5668227    m.m.voermans@amc.uva.nl   
Universitair Medisch Centrum Utrecht - Rudolf Magnus Instituut voor Neurowetenschappen Recruiting
Utrecht, Netherlands, 3584 CG
Contact: Leonard Van den Berg, Prof., Dr.    020 5668227    t.bunte-3@umcutrecht.nl   
Spain
Hospital de Basurto Recruiting
Bilbao, Vizcaya, Spain, 48013
Contact: Luis Verona       luis.varonafranco@osakidetza.eus   
Hospital Universitari de Bellvitge Recruiting
Barcelona, Spain, 08207
Contact: Eva Farrero Muñoz         
Contact: Berta Blanco Burguet    +34932607586      
Hospital Universitario Reina Sofia Recruiting
Córdoba, Spain, 14011
Hospital San Rafael - Madrid Recruiting
Madrid, Spain, 28016
Contact: Jesus S Mora Pardina, Dr       ela.sanrafael@gmail.com   
Hospital Universitario y Politécnico de La Fe Recruiting
Valencia, Spain, 46026
Contact: Juan Francisco Vázquez       Vazquez_juacos@gva.es   
Contact: Paula Lizandra       Paula_lizandra@iislafe.ed   
Sweden
Norrlands Universitetssjukhus Recruiting
Umeå, Vasterbotten, Sweden, 90737
Contact: Peter M Andersen       ALSforskning@umu.se   
Centralsjukhuset Karlstad Recruiting
Karlstad, Sweden, 651 85
Karolinska Universitetssjukhuset Recruiting
Stockholm, Sweden, 14186
Contact: Karolina Palmback    08 51771231      
United Kingdom
Barts Health NHS Trust Recruiting
London, England, United Kingdom, E1 1BB
Contact: Aleksandar Radunovic, Dr         
Contact: Kimberley Allen-Phillbey    02035940637/8      
King's College Hospital NHS Foundation Trust Recruiting
London, England, United Kingdom, SE5 9RS
The Walton Centre NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L9 7LJ
Contact: C A Young, Prof    0 151 529-5666      
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Study Director: Merja Mäkitalo, CSD Orion Corporation, Orion Pharma

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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03505021     History of Changes
Other Study ID Numbers: 3119002
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Simendan
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs