ALS Therapy Development Institute

Arimoclomol in Amyotropic Lateral Sclerosis

Arimoclomol in Amyotropic Lateral Sclerosis

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
231
Phase:
3
Treatment Type:
Drug: Arimoclomol
Trial Type:
Randomized, parallel assignment, quadruple masking, placebo controlled
Sponsor:
Orphazyme
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
≥80% (SVC)
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
<18 months
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
No more than 2 hours/day
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
No
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
No

Update Notes:

4/8/2019Recruitment status at locations updated
3/4/2019Locations updated
2/19/2019Locations updated
2/5/2019Locations updated
1/30/2019Locations updated
1/15/2019Locations added
1/2/2019Locations updated
12/14/2018Locations updated
11/23/2018Locations updated
10/5/2018Locations updated
8/24/2018Locations updated
8/14/2018First patient dosed in trial.
4/9/2018Trial added

Locations:

University of Miami, Miami, 33136
University of Virginia Health System, Charlottesville, 22908
Hospital for Special Surgery, New York, 10021
Providence Brain & Spine Institute, Portland, 97213
Barrow Neurological Institute (BNI), Phoenix, 85013
HonorHealth Neurology, Phoenix, 85018
UC Irvine Health ALS and Neuromuscular Center, Orange, 92868
University of Kansas Medical Center (KUMC, Kansas City,, 66160
Montreal Neurological Institute and Hospital, Montréal, H3A 2B4
Hospital Universitario Vall d'Hebron ALS Unit. Consultas Externas; Office: 9-10-11, Barcelona, 08035
Hospital Carlos III Hospital Universitario La Paz, ALS Unit, Madrid, 28046
Umeå University Hospital, Umeå, 90737
University of Texas Southwestern Medical Center, Dallas, 75390
Sunnybrook Health Sciences Centre, Toronto, M4N 3M5
Centre Hospitalier Regional Universitaire, Montpel Hopital Gui De Chauliac, Montpellier, 34295
Instituti Clinica Scientifici Maugeri - IRCCS, Milano, 20138
Azienda Ospedaliero Universitaria (AUO) di Torino Citta'della Salute e della Scienza di Torino, Torino, 10126
University Medical Center Utrecht, utrecht, 3584CX
UPenn, Perelman Center for Advanced Medicine Penn Neuroscience Center, Philadelphia, 19107
Groupe Hospitalier Pitie-Salpetriere Centre d'Investigation Clinique Neurosciences 1422, Paris, 75013
The University of Iowa The Institute for Clinical & Translational Science, Iowa CIty, 52242
Belgium Catholic University Leuven, Leuven, 3000
Leonard Wolfson Experimental Neurology Centre, London, WC1N 3BG
Charite - Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) - Ambulanz fuer ALS , Berlin, 13353
Medizinische Hochschule Hannover (MHH) Klinik fuer Neurologie, Hannover
Universitaetsklinikum Ulm - Klinik fuer Neurologie, Ulm
Centrum Medyczne NeuroProtect, Warsaw
Citi Clinic, Warsaw
Kantonsspital St.Gallen, Muskelzentrum/ALS Clinic`, Saint Gallen

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:
ALS Forum:
First Published on Clinicaltrials.gov: 3/27/2018
ClinicalTrials.gov ID: NCT03491462
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov