Interventional {{label}}

Open Label Extension of TUDCA-ALS Study

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

Intervention or Drug Name

Sponsor

Trial Status

Phase

Randomization

Trial Duration

Route of Administration

Genetic Target

Repurposed Drugs

Approved by FDA

Approved outside USA

Is a supplement

Details

Enrollment Criteria

Time since symptom onset

Vital Capacity (FVC or SVC)

Approved Medications

Registry Listing

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Purpose

This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.

What participation looks like

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

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

Locations

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Location Contact: {{location.Contact.Name}} {{location.Contact.Name}} Phone: {{location.Contact.Phone}}

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