Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial

Stopped early · Phase 3

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS) who have completed the ORARIALS-01 trial.

Key facts

Study ID

NCT03836716

Run by

ZevraDenmark

People needed

120

Starts

2019-09-19

Expected to finish

2021-07-02

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 is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures, or in the circumstance that the subject is incompetent, informed consent/assent is provided in accordance with local regulation and/or procedures
• Subject has completed the ORARIALS-01 trial (i.e., met one of the surrogate survival endpoints of tracheostomy or PAV or has completed the 76 weeks randomized treatment period)
• Subject completed ORARIALS-01 while on treatment, where on treatment is defined as having taken the last dose of IMP within 2 weeks of the End of Trial visit (whether at week 76 or prior)

You may not qualify if…

• Known or suspected allergy or intolerance to the IMP (Arimoclomol or constituents)
• Exposure to any other investigational treatment, advanced therapy medicinal product or use of any other prohibited concomitant medications
• Women who are lactating or pregnant, or men or women unwilling to use a highly effective method of birth control if not surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants until 3 months after last dose. Pre-menopausal women must have a negative pregnancy test prior to dosing with trial medication.
• Any of the following medically significant conditions:
• Clinically significant renal or hepatic disease OR clinical laboratory assessment (results ≥ 3 times the upper limit of normal [ULN] for aspartate aminotransferase and/or alanine aminotransferase, bilirubin ≥ 2 times the ULN, or creatinine ≥ 1.5 times the ULN).
• Any new condition or worsening of existing condition which, in the opinion of the investigator, would put the subject at undue risk.
• Any serious adverse event or moderate/severe adverse event from the ORARIALS-01 trial which is ongoing at the time of transitioning to ORARIALS-02 and assessed as probably related to IMP

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
• UC Irvine Health ALS and Neuromuscular Center — Orange, California, United States
• University of Miami — Miami, Florida, 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 Virginia Health System — Charlottesville, Virginia, United States
• Catholic University Leuven — Leuven, Belgium
• London Health Sciences Centre — London, Ontario, 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 — 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
• Leonard Wolfson Experimental Neurology Centre — London, United Kingdom

Full record on ClinicalTrials.gov

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