Open Label Extension of TUDCA-ALS Study (TUDCA-ALS OLE)
Amyotrophic Lateral Sclerosis
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Bile acids, Deoxycholic Acid
Eligibility Criteria
Inclusion Criteria: Completion of the visit M18 (Month 18) of the TUDCA-ALS clinical trial. Signed informed consent for participation in the TUDCA-ALS Extension sub-study Exclusion Criteria: Treatment with edaravone or other unaccepted concomitant therapy Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive TUDCA or that the subject is unable or unlikely to comply with the dosing schedule or study evaluations The patient of reproductive potential is sexually active and is not willing to use highly effective contraception during the study and up to 90 days after the day of last dose The patient is pregnant or breast feeding
Sites / Locations
- Katholieke Universiteit Leuven
- Centre Hospitalier Universitaire de BordeauxRecruiting
- Centre Hospitalier Universitaire LimogesRecruiting
- Centre Hospitalier Universitaire de MontpellierRecruiting
- Centre Hospitalier Regional Universitaire de ToursRecruiting
- Charité - Universitätsmedizin BerlinRecruiting
- Universitätsklinikum Carl Gustav Carus DresdenRecruiting
- Medizinische Hochschule Hannover
- Universitätsklinikum JenaRecruiting
- Universität Ulm
- Trinity College Dublin
- IRCCS Istituto Auxologico ItalianoRecruiting
- NEuroMuscular Omnicentre. Fondazione Serena OnlusRecruiting
- AOU Università degli Studi della Campania "Luigi Vanvitelli"Recruiting
- IRCCS Istituto Clinico Humanitas
- Azienda Ospedaliera Santa Maria di TerniRecruiting
- AOU Città della Salute e della Scienza di Torino
- Universitair Medisch Centrum Utrecht
- The Walton Centre NHS Foundation Trust
- Plymouth Hospitals NHS Trust
- Salford Royal NHS Foundation Trust
- University of SheffieldRecruiting
- Royal Stoke University HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Active treatment