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Quick Info
Status
Ongoing, But Not Recruiting
Estimated Enrollment
231
Phase
3
Treatment Type
Drug: Arimoclomol
Trial Type
Randomized, parallel assignment, quadruple masking, placebo controlled
Sponsor
Primary Investigator
Michael Benatar, MD PhD
Contact Information
Locations
Belgium, Other
Belgium Catholic University Leuven, Leuven, 3000, Belgium
Canada, Ontario
London Health Sciences Centre, London, ON, N6A 5A5, Canada
Sunnybrook Health Sciences Centre, Toronto, ON, M4N 3M5, Canada
Canada, Quebec
Montreal Neurological Institute and Hospital, Montréal, QC, H3A 2B4, Canada
Denmark, Other
Neuroligisk afdeling Aarhus Universitets Hospital , Aarhus, Denmark
Neurologisk afdeling Bispebjerg Hospital , Copenhagen, Denmark
France, Other
Centre Hospitalier Regional Universitaire, Montpel Hopital Gui De Chauliac, Montpellier, 34295, France
Groupe Hospitalier Pitie-Salpetriere Centre d'Investigation Clinique Neurosciences 1422, Paris, 75013, France
Germany, Other
Charite - Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) - Ambulanz fuer ALS , Berlin, 13353, Germany
Medizinische Hochschule Hannover (MHH) Klinik fuer Neurologie, Hannover, Germany
Universitaetsklinikum Ulm - Klinik fuer Neurologie, Ulm, Germany
Italy, Other
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
Netherlands, Other
University Medical Center Utrecht, utrecht, 3584CX, Netherlands
Poland, Other
Centrum Medyczne NeuroProtect, Warsaw, Poland
Citi Clinic, Warsaw, Poland
Spain, Other
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
Sweden, Other
Umeå University Hospital, Umeå, 90737, Sweden
Switzerland, Other
Kantonsspital St.Gallen, Muskelzentrum/ALS Clinic`, Saint Gallen, Switzerland
United Kingdom, Other
Leonard Wolfson Experimental Neurology Centre, London, WC1N 3BG, United Kingdom
United States, Arizona
Barrow Neurological Institute (BNI), Phoenix, AZ, 85013, United States
HonorHealth Neurology, Phoenix, AZ, 85018, United States
United States, California
UC Irvine Health ALS and Neuromuscular Center, Orange, CA, 92868, United States
United States, Florida
University of Miami, Miami, FL, 33136, United States
United States, Iowa
The University of Iowa The Institute for Clinical & Translational Science, Iowa CIty, IA, 52242, United States
United States, Kansas
University of Kansas Medical Center (KUMC, Kansas City,, KS, 66160, United States
United States, New York
Hospital for Special Surgery, New York, NY, 10021, United States
United States, Oregon
Providence Brain & Spine Institute, Portland, OR, 97213, United States
United States, Pennsylvania
UPenn, Perelman Center for Advanced Medicine Penn Neuroscience Center, Philadelphia, PA, 19107, United States
United States, Texas
University of Texas Southwestern Medical Center, Dallas, TX, 75390, United States
United States, Virginia
University of Virginia Health System, Charlottesville, VA, 22908, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
≥80% (SVC)
Months Since Onset
Number of months since first symptoms of ALS.
<18 months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
No more than 2 hours/day
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
No
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
No
Update Notes
No significant update
2/18/2020
Recruitment status updated
7/1/2019
Locations updated
6/5/2019
Recruitment status at locations updated
4/8/2019
Locations updated
3/4/2019
Locations updated
2/19/2019
Locations updated
2/5/2019
Locations updated
1/30/2019
Locations added
1/15/2019
Locations updated
1/2/2019
Locations updated
12/14/2018
Locations updated
11/23/2018
Locations updated
10/5/2018
Locations updated
8/24/2018
First patient dosed in trial.
8/14/2018
Trial added
4/9/2018

Other Information

Purpose
A multi center, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotrophic lateral sclerosis (ALS). NOTE: no sites are listed, but the company says there will be enrollment sites in US, Canada and the EU. Emailing or calling via the information below is recommended if interested.
Eligibility
18 Years and older, all genders, not accepting healthy volunteers
Details
Screening of up to 4 weeks Treatment of up to 76 weeks
Collaborator(s)
    -
News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT03491462 (First Published: 3/27/2018)