Trial record 2 of 13 for:
TUDCA | ALS
Open Label Extension of TUDCA-ALS Study (TUDCA-ALS OLE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05753852 |
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Recruitment Status :
Recruiting
First Posted : March 3, 2023
Last Update Posted : March 3, 2023
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Sponsor:
Humanitas Mirasole SpA
Collaborators:
University of Ulm
University of Sheffield
University Hospital, Tours
KU Leuven
UMC Utrecht
University of Dublin, Trinity College
Bruschettini S.r.l.
Istituto Superiore di Sanità
Motor Neurone Disease Association
Information provided by (Responsible Party):
Humanitas Mirasole SpA
- Study Details
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Brief Summary:
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Amyotrophic Lateral Sclerosis | Drug: Tauroursodeoxycholic Acid | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 184 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | October 25, 2021 |
| Estimated Primary Completion Date : | March 31, 2025 |
| Estimated Study Completion Date : | March 31, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Amyotrophic lateral sclerosis
Drug Information
available for:
Taurursodiol
| Arm | Intervention/treatment |
|---|---|
| Experimental: Active treatment |
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
Other Name: TUDCA,Tudcabil, Taurolite |
Primary Outcome Measures :
- Long-term safety and tolerability of TUDCA during the open-label phase [ Time Frame: 18 months ]Long-term safety and tolerability assessed through adverse reaction, concomitant treatment, and routine biochemistry analyses
Secondary Outcome Measures :
- Survival time [ Time Frame: 18 months ]Survival time measured by death or respiratory insufficiency (defined as tracheostomy or the use of non-invasive ventilation for ≥22 h per day for ≥10 consecutive days).
- Change in disease progression and functional impairment [ Time Frame: 18 months ]Change in disease progression and functional impairment as measured by ALSFRS-R.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05753852
Contacts
| Contact: Alberto Albanese, MD | +39-0282246418 | alberto.albanese@humanitas.it |
Locations
Show 23 study locations
Sponsors and Collaborators
Humanitas Mirasole SpA
University of Ulm
University of Sheffield
University Hospital, Tours
KU Leuven
UMC Utrecht
University of Dublin, Trinity College
Bruschettini S.r.l.
Istituto Superiore di Sanità
Motor Neurone Disease Association
| Responsible Party: | Humanitas Mirasole SpA |
| ClinicalTrials.gov Identifier: | NCT05753852 |
| Other Study ID Numbers: |
H2020/755094/2017/OLE |
| First Posted: | March 3, 2023 Key Record Dates |
| Last Update Posted: | March 3, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Humanitas Mirasole SpA:
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Bile acids Deoxycholic Acid |
Additional relevant MeSH terms:
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Amyotrophic Lateral Sclerosis Ursodoxicoltaurine Motor Neuron Disease Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases |
TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Antiviral Agents Anti-Infective Agents Cholagogues and Choleretics Gastrointestinal Agents |