Study Purpose:
A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Arimoclomol, Placebo oral capsule
Placebo:
Yes
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Michael Benatar, MD PhD, University of Miami
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Full Study Summary:
Screening of up to 4 weeks Treatment of up to 76 weeks
Study Sponsor:
ZevraDenmark
Participant Duration:
Screening of up to 4 weeks Treatment of up to 76 weeks
Estimated Enrollment:
245
Estimated Study Start Date:
07 / 31 / 2018
Estimated Study Completion Date:
12 / 18 / 2020
Posting Last Modified Date:
01 / 20 / 2021
Date Study Added to neals.org:
04 / 09 / 2018
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
Inclusion Criteria:- Subject meets revised El Escorial criteria for clinically possible, clinically probable / Clinically probable ALS laboratory-supported or clinically definite ALS, or familial ALS
- 18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria, dysphagia, shortness of breath).
- ALSFRS-R equal to or above 35 and erect (seated) SVC% predicted equal to or above 70% at screening
Exclusion Criteria:
- Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking hours at the time of screening or 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
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
Phoenix, Arizona
85013
United States
HonorHealth Neurology
Phoenix, Arizona
85018
United States
UC Irvine Health ALS and Neuromuscular Center
Orange, California
92868
United States
University of Miami
Miami, Florida
33136
United States
University of Kansas Medical Center (KUMC) - Landon Center on Aging
Kansas City, Kansas
66160
United States
Hospital for Special Surgery
New York, New York
10021
United States
Providence Brain & Spine Institute
Portland, Oregon
97213
United States
University of Pensylvania, Perelman Center for Advanced Medicine - Penn Neuroscience Center
Philadelphia, Pennsylvania
19107
United States
University of Texas Southwestern Medical Center
Dallas, Texas
75390
United States
University of Virginia Health System
Charlottesville, Virginia
22908
United States
Catholic University Leuven
Leuven 3000
Belgium
London Health Sciences Centre
London, Ontario
N6A 5A5
Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario
M4N 3M5
Canada
Montreal Neurological Institute and Hospital
Montréal, Quebec
H3A 2B4
Canada
Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Gui De Chauliac
Montpellier 34295
France
Groupe Hospitalier Pitie-Salpetriere - Centre d'Investigation Clinique Neurosciences 1422
Paris 75013
France
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Ambulanz fuer ALS und andere Motoneuronenerkrankungen
Berlin 13353
Germany
Medizinische Hochschule Hannover (MHH) - Klinik fuer Neurologie
Hannover 30625
Germany
Universitaetsklinikum Ulm - Klinik fuer Neurologie
Ulm 89081
Germany
Instituti Clinica Scientifici Maugeri - IRCCS
Milano 20138
Italy
Azienda Ospedaliero Universitaria (AUO) di Torino - Citta'della Salute e della Scienza di Torino
Torino 10126
Italy
University Medical Center Utrecht
Utrecht 3584CX
Netherlands
Centrum Medyczne NeuroProtect
Warsaw 01-684
Poland
Citi Clinic
Warsaw 02-473
Poland
Hospital Universitario Vall d'Hebron ALS Unit. Consultas Externas; Office: 9-10-11
Barcelona 08035
Spain
Hospital Carlos III - Hospital Universitario La Paz, ALS Unit
Madrid 28046
Spain
Umeå University Hospital
Umeå 90737
Sweden
Kantonsspital St.Gallen, Muskelzentrum/ALS Clinic
Saint Gallen 9007
Switzerland
Leonard Wolfson Experimental Neurology Centre
London WC1N 3BG
United Kingdom