Amyotrophic Lateral SclerosisPhase 3TUDCA-ALS OLENCT05753852
Open Label Extension of TUDCA-ALS Study
A Phase 3 study testing Tauroursodeoxycholic Acid in people with Amyotrophic Lateral Sclerosis, run by Humanitas Mirasole SpA at 23 sites in 7 countries.
Trial summary
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Tauroursodeoxycholic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 23 sitesin 7 countries
- Study dates
- 25 Oct 2021to 31 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
Italy6 sites, 4 recruiting
- Recruiting
IRCCS Istituto Auxologico Italiano
Milan
Vincenzo Silani, MD
- Recruiting
NEuroMuscular Omnicentre. Fondazione Serena Onlus
Milan
Valeria Sansone, MD
- Recruiting
AOU Università degli Studi della Campania "Luigi Vanvitelli"
Naples
Gioacchino Tedeschi, MD
- Active, not recruiting
IRCCS Istituto Clinico Humanitas
Rozzano
- Recruiting
Azienda Ospedaliera Santa Maria di Terni
Terni
Carlo Colosimo, MD
- Active, not recruiting
AOU Città della Salute e della Scienza di Torino
Torino
Germany5 sites, 3 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin
Thomas Meyer, MD
- Recruiting
Universitätsklinikum Carl Gustav Carus Dresden
Dresden
Robert Untucht, MD
- Active, not recruiting
Medizinische Hochschule Hannover
Hanover
- Recruiting
Universitätsklinikum Jena
Jena
Annekathrin Rödiger, MD
- Active, not recruiting
Universität Ulm
Ulm
United Kingdom5 sites, 2 recruiting
- Active, not recruiting
The Walton Centre NHS Foundation Trust
Liverpool
- Withdrawn
Plymouth Hospitals NHS Trust
Plymouth
- Withdrawn
Salford Royal NHS Foundation Trust
Salford
- Recruiting
University of Sheffield
Sheffield
Christopher J McDermott, MD
- Recruiting
Royal Stoke University Hospital
Stoke
Thomas Lambert, MD
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire de Bordeaux
Bordeaux
Gwendal Lemasson, MD
- Recruiting
Centre Hospitalier Universitaire Limoges
Limoges
Philippe Couratier, MD
- Recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier
Florence Esselin, MD
- Recruiting
Centre Hospitalier Regional Universitaire de Tours
Tours
Philippe Corcia, MD
Netherlands1 site
- Active, not recruiting
Universitair Medisch Centrum Utrecht
Utrecht
About this study
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
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.
Read the 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
- Amyotrophic Lateral Sclerosis
- Being tested
- Tauroursodeoxycholic Acid
- Keywords
- Bile acids, Deoxycholic Acid
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tauroursodeoxycholic AcidDrug
Also called TUDCA,Tudcabil, Taurolite
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
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Not described Receives: Drug: Tauroursodeoxycholic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety and tolerability of TUDCA during the open-label phase
Long-term safety and tolerability assessed through adverse reaction, concomitant treatment, and routine biochemistry analyses
Measured: 18 months
Secondary outcomes (2)
Survival time
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).
Measured: 18 months
Change in disease progression and functional impairment
Change in disease progression and functional impairment as measured by ALSFRS-R.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start25 Oct 2021
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Mirasole SpA
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753852
- Sponsor's protocol ID
- H2020/755094/2017/OLE
- Acronym
- TUDCA-ALS OLE
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05753852
- Acronym / sponsor ID
- TUDCA-ALS OLE / H2020/755094/2017/OLE
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Bile acids, Deoxycholic Acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Humanitas Mirasole SpAUniversity, hospital or other
- 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
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Drug: Tauroursodeoxycholic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tauroursodeoxycholic AcidAlso: TUDCA,Tudcabil, TauroliteTauroursodeoxycholic 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 | Drug | Active treatment |
Primary outcome
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
2 secondary outcomes
Survival time
Time frame: 18 months
Change in disease progression and functional impairment
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tauroursodeoxycholic Acid in people with Amyotrophic Lateral Sclerosis, run by Humanitas Mirasole SpA at 23 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Italy, Germany, United Kingdom, France, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Albanese, MD (+39-0282246418, alberto.albanese@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety and tolerability of TUDCA during the open-label phase (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.