Trials / Unknown
UnknownNCT05753852
Open Label Extension of TUDCA-ALS Study
Open Label Extension Study to Investigate Long Term Safety, Tolerability and Efficacy of Tauroursodeoxycholic Acid in Patients With ALS Who Completed the TUDCA-ALS Study
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- Sponsor
- Humanitas Mirasole SpA · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-10-25
- Primary completion
- 2025-03-31
- Completion
- 2025-03-31
- First posted
- 2023-03-03
- Last updated
- 2023-03-03
Locations
23 sites across 7 countries: Belgium, France, Germany, Ireland, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT05753852. Inclusion in this directory is not an endorsement.