Arimoclomol in Amyotropic Lateral Sclerosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)

Key facts

Study ID

NCT03491462

Run by

ZevraDenmark

People needed

245

Starts

2018-07-31

Expected to finish

2020-12-18

Last updated by the study team

2023-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject meets revised El Escorial criteria for clinically possible, clinically probable / clinically probable ALS laboratory-supported, clinically definite ALS or clinically definite familial ALS laboratory-supported
• 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

You may not qualify if…

• Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking hours at the time of Screening and Baseline
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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