RolloverTreatment With Triumeq for People With ALS Following the Lighthouse II Trial

Last updated: April 9, 2025
Sponsor: Macquarie University, Australia
Overall Status: Active - Enrolling

Phase

3

Condition

Scar Tissue

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)

Clinical Study ID

NCT06658977
MQ2024003
  • Ages > 18
  • All Genders

Study Summary

Triumeq is an approved medicine for HIV. The effectiveness of Triumeq in Amyotrophic Lateral Sclerosis (ALS) is being investigated in the Lighthouse II trial. This study aims to assess whether Triumeq is safe and effective at delaying ALS disease progression when given long term. It is available for participants who have completed the Lighthouse II study. The main measurements are safety, tolerability and survival.

The study will go for approximately 2 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants diagnosed with ALS according to the Lighthouse II protocol whocompleted the Lighthouse II trial.

  • Participants taking Riluzole must be on a stable dose.

  • Participants taking taurursodiol supplements (TUDCA) can participate in this trialif the supplement does not contain sodium phenylbutyrate.

  • Women must not become pregnant (e.g., post-menopausal, surgically sterile, usinghighly effective birth control methods or not having potentially reproductive sex)for the duration of the study plus five days; and women of childbearing potentialmust have a negative urine pregnancy test at baseline and be non-lactating.

  • For participants taking antacids (regularly or as required), participant is willingand able to avoid taking antacids for at least 6 hours before and 2 hours after theTriumeq dose.

  • Capable of providing informed consent and complying with the trial procedures.

Exclusion

Exclusion Criteria:

  • In the Principal Investigator's opinion, the participant is unlikely to be compliantwith the study drug dosing.

  • People who are HLA-B*5701 positive.

  • Presence of HIV antibodies at screening

  • Presence of Hepatitis C antibodies at screening unless participants have hadeffective treatment for Hepatitis C

  • Presence of Hepatitis B core or surface antigen at screening

  • Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of theexcipients.

  • Moderate to severe hepatic impairment, as defined by local clinical guidelines.

  • Participation in any other investigational drug trial or using anotherinvestigational drug within 5 half-lives of that drug.

  • Use of NIV ≥22 h per day or having a tracheostomy

  • Clinically significant history of unstable or severe cardiac, oncological,psychiatric, hepatic, or renal disease or other medically significant illness

  • Taking medication contraindicated with Triumeq: Dofetilide or Fampridine (dalfampridine)

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)
Phase: 3
Study Start date:
November 15, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Treatment options for ALS are very limited and there is a high unmet need for effective treatments. Triumeq targets a known neuron toxic pathway and is currently under investigation in a double blind placebo controlled trial, Lighthouse II. This study will be open to participants who took part in, and were still taking the study drug when they completed the Lighthouse II trial, in Australia and New Zealand.

The nature of the target and the mechanism of action of Triumeq are well understood. Participation in this rollover study is concurrent with standard of care, so participants are not limited in their use of therapies.

Participants will be assessed for adverse events, discontinuation of study medication, survival, measures of daily functioning, plus biomarker assessments of blood and urine samples.

Participant contacts may be face to face, or remote, and will be at 3 monthly intervals until approx December 2026 by which time it is anticipated the results of the Lighthouse II study will be available.

Connect with a study center

  • Macquarie University, Neurology

    North Ryde, New South Wales 2109
    Australia

    Site Not Available

  • Neuroscience Research Australia (NeuRA)

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Royal Brisbane and Womens Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, S.A. 5042
    Australia

    Site Not Available

  • Launceston General Hospital

    Launceston, Tasmania 7250
    Australia

    Site Not Available

  • Calvary Health Care Bethlehem

    Caulfield South, Victoria 3162
    Australia

    Site Not Available

  • The Perron Institute

    Nedlands, W.A. 6009
    Australia

    Site Not Available

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