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Recruiting
NCT05753852
Open Label Extension of TUDCA-ALS Study
Conditions: Amyotrophic Lateral Sclerosis
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 184
Sponsor: Humanitas Mirasole SpA
Location: Belgium
Summary
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.
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-studyExclusion Criteria:Treatment with edaravone or other unaccepted concomitant therapyConsideration 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 evaluationsThe 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 doseThe patient is pregnant or breast feeding
Source: ClinicalTrials.gov (NCT05753852). StuddyBuddy aggregates publicly available trial information.