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Open Label Extension of TUDCA-ALS Study

NCT05753852 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2023-03-03

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Tauroursodeoxycholic Acid

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

Sponsors & Collaborators

  • University of Ulm

    collaborator OTHER

  • University of Sheffield

    collaborator OTHER

  • University Hospital, Tours

    collaborator OTHER

  • KU Leuven

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • University of Dublin, Trinity College

    collaborator OTHER

  • Bruschettini S.r.l.

    collaborator UNKNOWN

  • Istituto Superiore di Sanità

    collaborator OTHER

  • Motor Neurone Disease Association

    collaborator UNKNOWN

  • Humanitas Mirasole SpA

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Belgium
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05753852 on ClinicalTrials.gov