TUDCA-ALS Clinical Trial Is Recruiting

[Ellie]

The TUDCA-ALS Clinical Trial is recruiting participants for its trial across 7 sites in the UK & Ireland.

Further information: https://mndresearch.blog/2019/11/25/tudca-als/

Love Ellie.

[Lynne K]

How do you sign up Ellie? I clicked on your link and couldn't find anywhere to ask to join. I'd go to Salford. Thanks, Lynne

[Ellie]

Hi Lynne,

As you attend a clinic involved in the trial (Salford), your Neurologist can sign you up if you're eligble.

For people not attending one of the listed trial clinics, your Neurologist can refer you to one of the participating clinics.

As usual, there are eligibility criteria:

Inclusion Criteria:

• Either gender
• 18 to 80 years of age (inclusive)
• Probable, laboratory-supported probable or definite ALS as defined by El Escorial Re-vised ALS diagnostic criteria
• Disease duration ≤ 18 months
• No swallowing difficulties (4 on ALSFRS-R subscore for swallowing)
• Forced vital capacity ≥70% of normal
• Stable on riluzole treatment for 3 months in the lead-in period (month -3 to month 0) or no riluzole
• Signed informed consent

Exclusion Criteria:

• Other causes of neuromuscular weakness
• Presence of other neurodegenerative diseases
• Significant cognitive impairment, clinical dementia or psychiatric illness
• Severe cardiac or pulmonary disease
• Other diseases precluding functional assessments
• Other life-threatening diseases
• Women of child-bearing age without contraception, who are pregnant or breast feeding
• Any clinically significant laboratory abnormality
• Other concurrent investigational medications
• Active peptic ulcer
• Previous surgery or infections of small intestine
• Patients unable to easily swallow the treatment pills at time of enrolment
• Occurrence of frequent biliary colic, biliary infections, severe pancreatic abnormalities
• Subjects who weigh 88lbs (40 kgs) or less at screening
• Aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
• Creatinine clearance of 50ml/min or less
• Previous exposure to bile acids
• Any clinically significant neurological, haematological, auto-immune, endocrine, cardiovascular, neoplastic, renal, gastro-intestinal, or other disorder that, in the investigator’s opinion, could interfere with subject’s participation in the study, place the subject at increased risk, or confound interpretation of study results
• 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

Love Ellie.

[Lynne K]

Thanks Ellie. I'm seeing my neurologist at her Salford clinic Wednesday 11th December, that's 2 weeks away. I'll ask her. I hope that it doesn't book up by then. Thanks, Lynne

[Lynne K]

Does anybody know what 4 is for swallowing on the ALSFRS-R Sub Category scale please. Thanks, Lynne

[Lynne K]

I just looked online for an ALSFRS-R Scale. 4 is the 'normal'function and '0' the worst. Lynne

[nunhead_man]

Good morning

I saw this coming through on the MND research blog and so contacted my local team at Kings.

They will refer me, although unfortunately there is no very close participating centre - none of the London ones seem to be participating

But having double checked the criteria I see one of them is you have to be diagnosed less than eighteen months ago, which of course is not me

[Ellie]

But having double checked the criteria I see one of them is you have to be diagnosed less than eighteen months ago, which of course is not me

It's actually even more restrictive than that, Andy - disease duration must be ≤ 18 months, i.e. from symptom onset.

[Kayleigh]

Many thanks for kindly letting us know about the trial Ellie.

I won't be eligible for this trial (partly because it has been more than 18 months since the start of my symptoms).

However, even if I don't meet the criteria for a trial, I find it encouraging to read about any ongoing or new medical research into MND - and people who are new to the this forum might be interested to know that the MNDA have a 'Take part in Research' webpage (which includes links to further information about this trial):-

http://https://www.mndassociation.org/research/get-involved-in-research/take-part-in-research/

Thank you again Ellie & love and best wishes to you and your family,

Kayleigh x

[Lynne K]

Kayleigh, I'm hoping that I can join the trial despite over 2 years since my diagnosis. My only concern is having to have no swallowing issues, a score of 4 on the ALSFRS-R Swallowing Sub Category. I eat whatever I want and take pills fairly easily but I couldn't say absolutely no issues. They may reject me . I have an appointment at my neurology clinic in two weeks so I'll ask about it then.

Lynne x

[Kayleigh]

Hi Lynne

I can understand why they would want people to have a score of 4 for swallowing (because they obviously don't want a patient to choke on the tablets or have any discomfort while swallowing them) but perhaps check with your neurologistist whether you have been scored a 3 or 4 so far?

I found an online version of the scale and it says a score of 3 is 'early eating problems - occasional choking' (I can't remember if this is the version currently used by the NHS though?):-

http://https://www.neurotoolkit.com/alsfrs-r/

I hope all goes well at your next hospital appointment.

Love
Kayleigh

[Lynne K]

Thanks Kayleigh x

[Timm]

do you know which tudca brand they are using at the trial ?

is it a supplement or a drug ?

[Kayleigh]

Hello Timm

The EU Clinical Trials Register has got the Trade Name of the drug listed as 'Taurolite':-

http://https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002722-22/GB

The purpose of the trial is to find out if it can be used as an effective treatment in addition to Riluzole.

Further information about the trial:-
http://https://www.mndassociation.org/research/get-involved-in-research/take-part-in-research/tudca-clinical-trial/

Best wishes
Kayleigh

[Timm]

thanks kayleigh

what would be the possible outcomes of this drug do you think ?