TUDCA clinical trial
Testing the safety and effect of tauroursodeoxycholic acid (TUDCA) on disease progression.
TUDCA-ALS (Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS)) is a European run clinical trial taking place in Italy, Germany, UK, France, Belgium, the Netherlands and Ireland. This trial will test the effectiveness and safety of using TUDCA in people with MND. The trial will look at the effects (both good and bad) of TUDCA on people with MND and if it slows down the advance of the disease.
What does taking part involve?
Initially you will undergo a ‘screening’ evaluation to confirm your eligibility to take part in the study. This evaluation will also include taking blood samples and samples of your cerebrospinal fluid (CSF) to act as a baseline for the start of the study.
After 3 months you will be re-screened for eligibility to confirm that you are able to continue on the study (the 3-month period is also to be able to assess whether you are stable whilst taking riluzole). People that are not taking riluzole are able to take part in the trial but cannot begin to take riluzole during the study.
You will then begin to receive the treatment capsules (either TUDCA or placebo). You will take 4 capsules in the morning and again in the evening. Throughout the 18-month period you will be asked to visit the clinic every 3 months for routine checks of your symptoms. At some of these visits, you will also be asked to provide samples of blood and cerebrospinal fluid.
Sheffield (Royal Hallamshire Hospital), Preston (Preston Hospital), Liverpool (The Walton Centre), Plymouth (Derriford Hospital), Salford (Salford Royal Hospital), Stoke (Royal Stoke University Hospital), Dublin (Beaumont Hospital).
Who can take part?
People living with ALS, who:
• are less than 18 months since symptom onset
• no swallowing difficulties
How do I take part?
If you think that you may be eligible, speak to your local MND neurologist so they can refer you to one of the recruitment centres.
Read our information sheet DB: TUDCA-ALS for more detailed information.
You can also find this trial at clinicaltrials.gov.
This is funded by the European Union’s Horizon 2020 research and innovation programme (No. 755094).
Expiry date: N/A