This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.
The TUDCA-ALS Open label extension study is designed to investigate long term safety, tolerability and efficacy of tauroursodeoxycholic acid in patients with ALS who completed the TUDCA-ALS study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Tauroursodeoxycholic acid (TUDCA) 250 mg capsules Doses: 4 capsules (1 g) twice daily 10-15 minutes after a meal Mode of administration: orally Duration: 18 months
Katholieke Universiteit Leuven
Leuven, Belgium
Long-term safety and tolerability of TUDCA during the open-label phase
Long-term safety and tolerability assessed through adverse reaction, concomitant treatment, and routine biochemistry analyses
Time frame: 18 months
Survival time
Survival time measured by death or respiratory insufficiency (defined as tracheostomy or the use of non-invasive ventilation for ≥22 h per day for ≥10 consecutive days).
Time frame: 18 months
Change in disease progression and functional impairment
Change in disease progression and functional impairment as measured by ALSFRS-R.
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
RECRUITINGCentre Hospitalier Universitaire Limoges
Limoges, France
RECRUITINGCentre Hospitalier Universitaire de Montpellier
Montpellier, France
RECRUITINGCentre Hospitalier Regional Universitaire de Tours
Tours, France
RECRUITINGCharité - Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGUniversitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
RECRUITINGMedizinische Hochschule Hannover
Hanover, Germany
ACTIVE_NOT_RECRUITINGUniversitätsklinikum Jena
Jena, Germany
RECRUITINGUniversität Ulm
Ulm, Germany
ACTIVE_NOT_RECRUITING...and 13 more locations