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TUDCA-ALS

  • Research type

    Research Study

  • Full title

    Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS)

  • IRAS ID

    257082

  • Contact name

    Chris McDermott

  • Contact email

    c.j.mcdermott@sheffield.ac.uk

  • Sponsor organisation

    IRCCS ISTITUTO CLINICO HUMANITAS

  • Eudract number

    2018-002722-22

  • Clinicaltrials.gov Identifier

    NCT03800524

  • Duration of Study in the UK

    2 years, 3 months, 30 days

  • Research summary

    Amyotrohic lateral sclerosis (ALS) is a neurodegenerative disease which affects around 40,000 people throughout Europe. Riluzole is the only drug currently available which can slow the progression of ALS. The TUDCA-ALS study will look at a new drug called taurousodeoxycholic acid (TUDCA). The aim of the study is to determine whether TUDCA has an impact on the progression of ALS.

    The study will be conducted in hospital sites across Europe with around 5-6 hospitals taking part in the UK. Participants will be randomly allocated to receive TUDCA or placebo twice a day for 18 months. TUDCA will usually be administered as an add-on treatment to riluzole although it may be administered alone for patients who are unable to tolerate riluzole. Participants will be required to undergo a 3 month lead-in phase prior to starting study treatment. During the lead-in phase, 3 study visits will take place at 6-weekly intervals. After starting study treatment, visits will take place every 3 months during the 18 month treatment phase.

    Disease progression will be measured throughout the treatment period and other assessments will also be completed to assess quality of life as well as the safety and tolerability of TUDCA.

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    19/EM/0097

  • Date of REC Opinion

    20 May 2019

  • REC opinion

    Further Information Favourable Opinion