Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
245 participants
INTERVENTIONAL
2018-07-31
2020-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arimoclomol
248 mg arimoclomol base (equivalent to 400 mg arimoclomol citrate) 3 times daily
Arimoclomol
2 capsules (2 x 124 mg arimoclomol base; equivalent to 2 x 200 mg arimoclomol citrate) taken 3 times daily
Placebo
248 mg matching placebo 3 times daily
Placebo
2 matched placebo capsules taken 3 times daily
Interventions
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Arimoclomol
2 capsules (2 x 124 mg arimoclomol base; equivalent to 2 x 200 mg arimoclomol citrate) taken 3 times daily
Placebo
2 matched placebo capsules taken 3 times daily
Eligibility Criteria
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Inclusion Criteria
* 18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria, dysphagia, shortness of breath)
* ALS Functional Rating Scale-Revised (ALSFRS-R) equal to or above 35 and erect (seated) Slow Vital Capacity (SVC) % predicted equal to or above 70% at Screening
Exclusion Criteria
* Pregnant or breast-feeding
* Current or anticipated use of diaphragmatic pacing
* Any other relevant medically significant condition which could present risk to the subject or interfere with the assessment of safety or has an increased risk of causing death during the trial
18 Years
ALL
No
Sponsors
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ZevraDenmark
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Benatar, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
Phoenix, Arizona, United States
HonorHealth Neurology
Phoenix, Arizona, United States
UC Irvine Health ALS and Neuromuscular Center
Orange, California, United States
University of Miami
Miami, Florida, United States
University of Kansas Medical Center (KUMC) - Landon Center on Aging
Kansas City, Kansas, United States
Hospital for Special Surgery
New York, New York, United States
Providence Brain & Spine Institute
Portland, Oregon, United States
University of Pensylvania, Perelman Center for Advanced Medicine - Penn Neuroscience Center
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Catholic University Leuven
Leuven, , Belgium
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Gui De Chauliac
Montpellier, , France
Groupe Hospitalier Pitie-Salpetriere - Centre d'Investigation Clinique Neurosciences 1422
Paris, , France
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Ambulanz fuer ALS und andere Motoneuronenerkrankungen
Berlin, , Germany
Medizinische Hochschule Hannover (MHH) - Klinik fuer Neurologie
Hanover, , Germany
Universitaetsklinikum Ulm - Klinik fuer Neurologie
Ulm, , Germany
Instituti Clinica Scientifici Maugeri - IRCCS
Milan, , Italy
Azienda Ospedaliero Universitaria (AUO) di Torino - Citta'della Salute e della Scienza di Torino
Torino, , Italy
University Medical Center Utrecht
Utrecht, , Netherlands
Centrum Medyczne NeuroProtect
Warsaw, , Poland
Citi Clinic
Warsaw, , Poland
Hospital Universitario Vall d'Hebron ALS Unit. Consultas Externas; Office: 9-10-11
Barcelona, , Spain
Hospital Carlos III - Hospital Universitario La Paz, ALS Unit
Madrid, , Spain
Umeå University Hospital
Umeå, , Sweden
Kantonsspital St.Gallen, Muskelzentrum/ALS Clinic
Sankt Gallen, , Switzerland
Leonard Wolfson Experimental Neurology Centre
London, , United Kingdom
Countries
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References
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Benatar M, Hansen T, Rom D, Geist MA, Blaettler T, Camu W, Kuzma-Kozakiewicz M, van den Berg LH, Morales RJ, Chio A, Andersen PM, Pradat PF, Lange D, Van Damme P, Mora G, Grudniak M, Elliott M, Petri S, Olney N, Ladha S, Goyal NA, Meyer T, Hanna MG, Quinn C, Genge A, Zinman L, Jabari D, Shoesmith C, Ludolph AC, Neuwirth C, Nations S, Shefner JM, Turner MR, Wuu J, Bennett R, Dang H, Sundgreen C; ORARIALS-01 trial team. Safety and efficacy of arimoclomol in patients with early amyotrophic lateral sclerosis (ORARIALS-01): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Neurol. 2024 Jul;23(7):687-699. doi: 10.1016/S1474-4422(24)00134-0. Epub 2024 May 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ORARIALS-01
Identifier Type: -
Identifier Source: org_study_id
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