Lighthouse II

  • Research type

    Research Study

  • Full title

    RANDOMISED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 3 TRIAL OF TRIUMEQ IN AMYOTROPHIC LATERAL SCLEROSIS

  • IRAS ID

    271218

  • Contact name

    Ammar Al-Chalabi

  • Contact email

    ammar.al-chalabi@kcl.ac.uk

  • Sponsor organisation

    King's College London

  • Eudract number

    2020-005069-15

  • ISRCTN Number

    ISRCTN88446415

  • Duration of Study in the UK

    5 years, 0 months, 2 days

  • Research summary

    What do you want to do?
    We want to see if Triumeq, a drug used to block viruses, might be effective in amyotrophic lateral sclerosis (ALS). To find out, we will be doing a clinical trial in which some people receive Triumeq, and others do not, so that we can compare the two groups of people.
    Why are you testing Triumeq in ALS?
    Every cell in the body contains instructions called genes, stored as DNA. Everybody’s DNA also
    carries genes for ancient viruses. These lie dormant but “hitch-hike” along with our genes. We know
    that these viruses can kill the nerve cells involved in ALS. We think that in people with ALS these
    viruses are activated, and help to cause the disease. Triumeq is very effective against these hitchhiking
    viruses, so it makes sense to test it in people with ALS.
    We have already shown that people with ALS can take Triumeq safely. Our next step is to try it in 300
    people with ALS to see if it is effective.
    How will you test it?
    We will carry out a clinical trial. People who take part will be chosen randomly to either receive
    Triumeq or a placebo. The placebo looks and tastes the same as Triumeq but does not have any
    Triumeq in it. Neither ourselves nor the people taking part will know who is taking Triumeq until the
    study ends. We will monitor the people in the trial for up to four years to see if taking Triumeq makes
    people live longer and slows down ALS.

  • REC name

    London - Westminster Research Ethics Committee

  • REC reference

    22/LO/0059

  • Date of REC Opinion

    1 Feb 2022

  • REC opinion

    Favourable Opinion