Triumeq in Amyotrophic Lateral Sclerosis (LIGHTHOUSE II)

July 8, 2025 updated by: Macquarie University, Australia

Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis

To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This Randomised Double-Blind Placebo Controlled trial seeks to investigate whether the combination medicine Triumeq (dolutegravir 50mg, abacavir 600mg, lamivudine 300mg), already sold in Australia for HIV treatment is effective in delaying progression of theAmyotrophic Lateral Sclerosis (ALS) disease and if it is safe and well tolerated in patients with ALS. This medication is very commonly prescribed for patients with HIV. The secondary aim of this study is to assess patient's health outcomes whilst taking this medication for their ALS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
419

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • North Ryde, New South Wales, Australia, 2109
        • MQ Health Neurology
      • Randwick, New South Wales, Australia, 2031
        • Neuroscience Research Australia (NeuRA)
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • Caulfield South, Victoria, Australia, 3162
        • Calvary Health Care Bethlehem
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • The Perron Institute
  • Ireland
      • Dublin, Ireland, D09V2N0
        • Beaumont Hospital
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Dunedin, New Zealand, 9054
        • Dunedin Hospital
      • Tauranga, New Zealand, 3112
        • Clinical Trials Unit, Tauranga Hospital
      • Wellington, New Zealand, 6021
        • Wellington Regional Hospital
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Univerzitetni klinicni center Ljubljana
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • València, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
  • Sweden
      • Stockholm, Sweden, 113 61
        • Studiecenheten at Akademiskt specialistcentrum
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SB
        • University of Edinburgh, Anne Rowling Regenerative Nuerology Clinic
      • Liverpool, United Kingdom, L9 7LJ
        • The Walton Centre
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Hospital
      • London, United Kingdom, NW1 2PG
        • University College London Hospital
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospital
      • Plymouth, United Kingdom, PL8 8DH
        • Plymouth University Hospital
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Sheffield, United Kingdom, S5 7AU
        • Sheffield Teaching Hospital
      • Stoke, United Kingdom, ST4 6QG
        • Royal Stoke Hotel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years at the time of screening
  2. Diagnosis of ALS according to the Gold Coast Criteria
  3. Capable of providing informed consent and complying with trial procedures
  4. TRICALS risk profile > -6.0 and < -2.0
  5. Those taking Riluzole must be on a stable dose for at least 30 days prior to the baseline visit or must have stopped taking Riluzole at least 30 days prior to the baseline visit
  6. Women must not become pregnant (e.g., post-menopausal, surgically sterile, using highly effective birth control methods or not having potentially reproductive sex) for the duration of the study plus five days. Highly effective methods of birth control are those with a failure rate of < 1% per year when employed consistently and correctly, e.g. Combined (oestrogen and progestogen containing) hormonal contraception or progestogen-only hormonal contraception. For more information, please refer to the HMA CTFG Guidelines: https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf?fbclid=IwAR3AY5Ha0ESDyqIBeUaYI9VTFWmx9bbt8NZ-80N-5ME6pkBb1UHvFsTwqlQ
  7. Women of childbearing potential must have a negative serum pregnancy test at screening and be non-lactating. Patients will be advised regarding appropriate contraception. A menstruation history will be taken at each visit. Women of childbearing potential are defined as females who are fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf?fbclid=IwAR3AY5Ha0ESDyqIBeUaYI9VTFWmx9bbt8NZ-80N-5ME6pkBb1UHvFsTwqlQ)
  8. For participants taking antacids (regularly or as required), participant is willing and able to avoid taking antacids for at least 6 hours before and 2 hours after Triumeq
  9. Participant taking taurursodiol supplements (TUDCA) can participate in this trial if the supplement does not contain sodium phenylbutyrate.
  10. Participants taking taurursodiol supplements (TUDCA) that also contain sodium phenylbutyrate must be willing to stop supplementation 30 days prior randomisation.

Exclusion Criteria:

  1. People who are HLA-B*5701 positive
  2. Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients

  3. Safety Laboratory Criteria at screening:

    • ALT ≥ 5 times upper limit of normal (ULN)
    • AST ≥ 3 times ULN
    • Bilirubin ≥ 1.5 times ULN with clinical indicators of liver disease
    • Creatinine clearance < 30 mL / min
    • Platelet concentration of < 100 x109 per L
    • Absolute neutrophil count of < 1x109 per L
    • Haemoglobin < 100 g/L
    • Amylase ≥ 2 times ULN
    • Lactate ≥ 2 times ULN
  4. Moderate to severe hepatic impairment, as defined by local clinical guidelines
  5. Presence of HIV antibodies at screening
  6. Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C
  7. Presence of Hepatitis B core or surface antigen at screening
  8. Participation in any other investigational drug trial or using investigational drug within 30 days prior to screening
  9. Use of NIV ≥22 h per day or having a tracheostomy
  10. Edaravone dose within 30 days prior to screening. Edaravone is approved by the FDA and in Japan, but remains an investigational product in Europe and Australia
  11. Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness
  12. Taking medication contraindicated with Triumeq: Dofetilideor Fampridine (dalfampridine)
  13. Taking Tofersen within 3 months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dolutegravir/Abacavir/Lamivudine

Combination of Dolutegravir, Abacavir and Lamivudine in a single product/capsule.

4 capsules to be taken orally once daily (all 4 at the same time, each capsule is Dolutegravir 12.5mg, Abacavir 150mg and Lamivudine 75mg). Maximum duration is 24months
Drug: Dolutegravir, Abacavir and Lamivudine
Dolutegravir 50mg, Abacavir 600mg and Lamivudine 300mg.
Other Names:
  • Triumeq
Placebo Comparator: Placebo
4 capsules to be taken orally once daily (all 4 at the same time). Maximum duration is 24months
Drug: Placebo
Matching placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure overall survival at 24 months or after a minimum of 212 events
Time Frame: 24 months
Overall survival is measured as death from any cause, in participants with ALS at 24 months, or after a minimum of 212 events.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measure scoring in the ALS-Functional Rating Scale Revised (ALSFRS-R) at 3 monthly intervals.
Time Frame: 24 months
The ALSFRS-R is a 12 item participant self-report measure that monitors ALS disease progression, where a higher score reflects a better outcome.
24 months
Number of participants with abnormal Slow Vital Capacity measured by hand spirometry at 3 monthly intervals
Time Frame: 24 months
Slow vital capacity is measured in litres, and as a % of predicted.
24 months
Measure plasma creatinine at 3 monthly intervals
Time Frame: 24 months
Plasma creatinine is assessed to monitor kidney function
24 months
Assign a value using the King's Staging Scale to describe degree of disease advancement over time
Time Frame: 24 months
The King's Staging Scale is a clinical staging system defining four stages of ALS assessed by way of a semi-structured interview with the participant.
24 months
Evaluate the incidence of treatment-emergent adverse events
Time Frame: 24 months
based on physical examinations and patient reported symptoms.
24 months
Measure study medication discontinuation
Time Frame: 24 months
the number of participants who discontinue study medication will be assessed to assess tolerability
24 months
Measure the score obtained with the Edinburgh Cognitive and Behavioural Assessment Screen (ECAS)
Time Frame: 24 months
ECAS is a multidomain assessment questionnaire used in ALS to assess cognitive and behavioural changes where a higher score relates to a better outcome.
24 months
Measure the responses in the EQ-5D-5L quality of life health questionnaire.
Time Frame: 24 months
The EQ-5D-5L questionnaire is a standardised measure of health-related Quality of Life, also incorporating a Visual Analogue Scale. A higher score relates to a better outcome.
24 months
Measurement of several biomarkers from blood and urine samples
Time Frame: 24 months
Urinary P75ECD, plasma neurofilament light and heavy chain, HERV-K expression and genotyping (UNC13a / C9orf72) will be measured for post-trial exploratory analyses.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Macquarie University, Australia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London
Stichting TRICALS Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julian Gold, MD, FFPHM, Macquarie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LIGHTHOUSE II
  • 2020-005069-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It is anticipated participant level data will be available as open access.

IPD Sharing Time Frame

Contact the Chief Investigators for access information.

IPD Sharing Access Criteria

Contact the Chief Investigators for access information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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