Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
419 participants
INTERVENTIONAL
2022-02-24
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Dolutegravir, Abacavir and Lamivudine
Dolutegravir 50mg, Abacavir 600mg and Lamivudine 300mg.
Placebo
4 capsules to be taken orally once daily (all 4 at the same time). Maximum duration is 24months
Placebo
Matching placebo.
Interventions
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Dolutegravir, Abacavir and Lamivudine
Dolutegravir 50mg, Abacavir 600mg and Lamivudine 300mg.
Placebo
Matching placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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King's College London
OTHER
Stichting TRICALS Foundation
OTHER
Macquarie University, Australia
OTHER
Responsible Party
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Principal Investigators
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Julian Gold, MD, FFPHM
Role: PRINCIPAL_INVESTIGATOR
Macquarie University
Locations
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MQ Health Neurology
North Ryde, New South Wales, Australia
Neuroscience Research Australia (NeuRA)
Randwick, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Calvary Health Care Bethlehem
Caulfield South, Victoria, Australia
The Perron Institute
Nedlands, Western Australia, Australia
Beaumont Hospital
Dublin, , Ireland
UMC Utrecht
Utrecht, , Netherlands
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Clinical Trials Unit, Tauranga Hospital
Tauranga, , New Zealand
Wellington Regional Hospital
Wellington, , New Zealand
Univerzitetni klinični center Ljubljana
Ljubljana, , Slovenia
Hospital del Mar
Barcelona, , Spain
Hospital Universitario y Politecnico la Fe
Valencia, , Spain
Studiecenheten at Akademiskt specialistcentrum
Stockholm, , Sweden
University of Edinburgh, Anne Rowling Regenerative Nuerology Clinic
Edinburgh, , United Kingdom
The Walton Centre
Liverpool, , United Kingdom
University College London Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Oxford University Hospital
Oxford, , United Kingdom
Plymouth University Hospital
Plymouth, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Sheffield Teaching Hospital
Sheffield, , United Kingdom
Royal Stoke Hotel
Stoke, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2020-005069-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LIGHTHOUSE II
Identifier Type: -
Identifier Source: org_study_id
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