Amyotrophic Lateral SclerosisPhase 3LIGHTHOUSE IINCT05193994
Triumeq in Amyotrophic Lateral Sclerosis
A Phase 3 study testing Dolutegravir, Abacavir and Lamivudine in people with Amyotrophic Lateral Sclerosis, run by Macquarie University, Australia at 28 sites in 8 countries.
Trial summary
To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Dolutegravir, Abacavir and Lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 419 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 24 Feb 2022to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of screening
- Diagnosis of ALS according to the Gold Coast Criteria
- Capable of providing informed consent and complying with trial procedures
- TRICALS risk profile > -6.0 and < -2.0
- 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
- 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
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- 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)
- 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
- Participant taking taurursodiol supplements (TUDCA) can participate in this trial if the supplement does not contain sodium phenylbutyrate.
- Participants taking taurursodiol supplements (TUDCA) that also contain sodium phenylbutyrate must be willing to stop supplementation 30 days prior randomisation.
Who cannot join
- People who are HLA-B*5701 positive
- Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients
- 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
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- 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
- Moderate to severe hepatic impairment, as defined by local clinical guidelines
- Presence of HIV antibodies at screening
- Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C
- Presence of Hepatitis B core or surface antigen at screening
- Participation in any other investigational drug trial or using investigational drug within 30 days prior to screening
- Use of NIV ≥22 h per day or having a tracheostomy
- 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
- Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness
- Taking medication contraindicated with Triumeq: Dofetilideor Fampridine (dalfampridine)
- Taking Tofersen within 3 months prior to screening.
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
United Kingdom10 sites
University of Edinburgh, Anne Rowling Regenerative Nuerology Clinic
Edinburgh, EH16 4SB
The Walton Centre
Liverpool, L9 7LJ
University College London Hospital
London, NW1 2PG
King's College Hospital
London, SE5 9RS
St George's Hospital
London, SW17 0QT
Oxford University Hospital
Oxford, OX3 9DU
Plymouth University Hospital
Plymouth, PL8 8DH
Royal Preston Hospital
Preston, PR2 9HT
Sheffield Teaching Hospital
Sheffield, S5 7AU
Royal Stoke Hotel
Stoke, ST4 6QG
Australia8 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Calvary Health Care Bethlehem
Caulfield South, Victoria, 3162
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Launceston General Hospital
Launceston, Tasmania, 7250
The Perron Institute
Nedlands, Western Australia, 6009
MQ Health Neurology
North Ryde, New South Wales, 2109
Neuroscience Research Australia (NeuRA)
Randwick, New South Wales, 2031
New Zealand4 sites
Christchurch Hospital
Christchurch, 8011
Dunedin Hospital
Dunedin, 9054
Clinical Trials Unit, Tauranga Hospital
Tauranga, 3112
Wellington Regional Hospital
Wellington, 6021
Spain2 sites
Hospital del Mar
Barcelona, 08003
Hospital Universitario y Politecnico la Fe
Valencia, 46026
About this study
Official title: 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
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Dolutegravir, Abacavir and Lamivudine, Placebo
- Keywords
- ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir, Abacavir and LamivudineDrug
Also called Triumeq
Dolutegravir 50mg, Abacavir 600mg and Lamivudine 300mg.
PlaceboDrug
Matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir/Abacavir/Lamivudine | Experimental | 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 Receives: Drug: Dolutegravir, Abacavir and Lamivudine |
| Placebo | Placebo comparator | 4 capsules to be taken orally once daily (all 4 at the same time). Maximum duration is 24months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure overall survival at 24 months or after a minimum of 212 events
Overall survival is measured as death from any cause, in participants with ALS at 24 months, or after a minimum of 212 events.
Measured: 24 months
Secondary outcomes (9)
Measure scoring in the ALS-Functional Rating Scale Revised (ALSFRS-R) at 3 monthly intervals.
The ALSFRS-R is a 12 item participant self-report measure that monitors ALS disease progression, where a higher score reflects a better outcome.
Measured: 24 months
Number of participants with abnormal Slow Vital Capacity measured by hand spirometry at 3 monthly intervals
Slow vital capacity is measured in litres, and as a % of predicted.
Measured: 24 months
Measure plasma creatinine at 3 monthly intervals
Plasma creatinine is assessed to monitor kidney function
Measured: 24 months
Assign a value using the King's Staging Scale to describe degree of disease advancement over time
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.
Measured: 24 months
Evaluate the incidence of treatment-emergent adverse events
based on physical examinations and patient reported symptoms.
Measured: 24 months
Measure study medication discontinuation
the number of participants who discontinue study medication will be assessed to assess tolerability
Measured: 24 months
Measure the score obtained with the Edinburgh Cognitive and Behavioural Assessment Screen (ECAS)
ECAS is a multidomain assessment questionnaire used in ALS to assess cognitive and behavioural changes where a higher score relates to a better outcome.
Measured: 24 months
Measure the responses in the EQ-5D-5L quality of life health questionnaire.
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.
Measured: 24 months
Measurement of several biomarkers from blood and urine samples
Urinary P75ECD, plasma neurofilament light and heavy chain, HERV-K expression and genotyping (UNC13a / C9orf72) will be measured for post-trial exploratory analyses.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start24 Feb 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Why it stopped: A planned interim analysis resulted in the recommendation that the trial be stopped. The results showed no benefit of Triumeq for people with ALS compared with placebo on survival, the primary outcome measure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised in a 2:1 ratio to receive either triumeq or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macquarie University, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Stichting TRICALS Foundation
- Responsible party
- Sponsor
- Investigators
- Julian Gold, MD, FFPHM, Principal investigator, Macquarie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193994
- Sponsor's protocol ID
- LIGHTHOUSE II
- Other IDs
- 2020-005069-15
- Acronym
- LIGHTHOUSE II
- Status last verified
- Jul 2025
- First submitted
- 6 Dec 2021
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is anticipated participant level data will be available as open access.
Publications
Gold J, Rowe DB, Kiernan MC, Vucic S, Mathers S, van Eijk RPA, Nath A, Garcia Montojo M, Norato G, Santamaria UA, Rogers ML, Malaspina A, Lombardi V, Mehta PR, Westeneng HJ, van den Berg LH, Al-Chalabi A. Safety and tolerability of Triumeq in amyotrophic lateral sclerosis: the Lighthouse trial. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Nov;20(7-8):595-604. doi: 10.1080/21678421.2019.1632899. Epub 2019 Jul 8.
PubMed 31284774
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT05193994
- Acronym / sponsor ID
- LIGHTHOUSE II / LIGHTHOUSE II
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A planned interim analysis resulted in the recommendation that the trial be stopped. The results showed no benefit of Triumeq for people with ALS compared with placebo on survival, the primary outcome measure.
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Macquarie University, AustraliaUniversity, hospital or other
- Collaborators
- King's College London, Stichting TRICALS Foundation
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomised in a 2:1 ratio to receive either triumeq or placebo
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir/Abacavir/Lamivudine | Experimental | Drug: Dolutegravir, Abacavir and LamivudineCombination 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 |
| Placebo | Placebo comparator | Drug: Placebo4 capsules to be taken orally once daily (all 4 at the same time). Maximum duration is 24months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years at the time of screening
- Diagnosis of ALS according to the Gold Coast Criteria
- Capable of providing informed consent and complying with trial procedures
- TRICALS risk profile > -6.0 and < -2.0
- 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
Key exclusion criteria (22 listed)
- People who are HLA-B*5701 positive
- Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients
- Safety Laboratory Criteria at screening:
- Moderate to severe hepatic impairment, as defined by local clinical guidelines
- Presence of HIV antibodies at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dolutegravir, Abacavir and LamivudineAlso: TriumeqDolutegravir 50mg, Abacavir 600mg and Lamivudine 300mg. | Drug | Dolutegravir/Abacavir/Lamivudine |
| PlaceboMatching placebo. | Drug | Placebo |
Primary outcome
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.
9 secondary outcomes
Measure scoring in the ALS-Functional Rating Scale Revised (ALSFRS-R) at 3 monthly intervals.
Time frame: 24 months
Number of participants with abnormal Slow Vital Capacity measured by hand spirometry at 3 monthly intervals
Time frame: 24 months
Measure plasma creatinine at 3 monthly intervals
Time frame: 24 months
Assign a value using the King's Staging Scale to describe degree of disease advancement over time
Time frame: 24 months
Evaluate the incidence of treatment-emergent adverse events
Time frame: 24 months
Measure study medication discontinuation
Time frame: 24 months
Measure the score obtained with the Edinburgh Cognitive and Behavioural Assessment Screen (ECAS)
Time frame: 24 months
Measure the responses in the EQ-5D-5L quality of life health questionnaire.
Time frame: 24 months
Measurement of several biomarkers from blood and urine samples
Time frame: 24 months
Results and safety
The study was stopped early (reason given: A planned interim analysis resulted in the recommendation that the trial be stopped. The results showed no benefit of Triumeq for people with ALS compared with placebo on survival, the primary outcome measure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 31284774Gold J, Rowe DB, Kiernan MC, Vucic S, Mathers S, van Eijk RPA, Nath A, Garcia Montojo M, Norato G, Santamaria UA, Rogers ML, Malaspina A, Lombardi V, Mehta PR, Westeneng HJ, van den Berg LH, Al-Chalabi A. Safety and tolerability of Triumeq in amyotrophic lateral sclerosis: the Lighthouse trial. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Nov;20(7-8):595-604. doi: 10.1080/21678421.2019.1632899. Epub 2019 Jul 8.
- Individual participant dataSharing planned: Yes. It is anticipated participant level data will be available as open access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Gold, MD, FFPHM principal investigator
Macquarie University
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dolutegravir, Abacavir and Lamivudine in people with Amyotrophic Lateral Sclerosis, run by Macquarie University, Australia at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United Kingdom, Australia, New Zealand, Spain, Ireland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: A planned interim analysis resulted in the recommendation that the trial be stopped. The results showed no benefit of Triumeq for people with ALS compared with placebo on survival, the primary outcome measure.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure overall survival at 24 months or after a minimum of 212 events (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05193994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.