Open Label Extension of TUDCA-ALS Study

Launched by HUMANITAS MIRASOLE SPA · Feb 23, 2023

Keywords

ClinConnect Summary

The Open Label Extension of the TUDCA-ALS Study is a clinical trial designed for patients who have already participated in the earlier TUDCA-ALS study, which looked at the effects of a treatment called TUDCA on Amyotrophic Lateral Sclerosis (ALS). This extension study aims to provide continued access to the TUDCA treatment and to see how patients fare over a longer period. If you are between the ages of 65 and 74 and have completed the 18-month visit of the TUDCA-ALS study, you may be eligible to join.

Participants in this trial can expect to continue receiving the TUDCA treatment while being monitored for their health outcomes. It’s important to note that if you are currently on certain other treatments or if the study team thinks you may not be able to follow the study requirements, you might not be able to participate. Additionally, women who could become pregnant must agree to use effective birth control during the study and for 90 days after their last dose. This study is currently recruiting participants, and if you meet the criteria, it could be a valuable opportunity to contribute to research on ALS while receiving ongoing treatment.

Gender

ALL

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