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Triumeq in Amyotrophic Lateral Sclerosis (LIGHTHOUSE II)

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ClinicalTrials.gov Identifier: NCT05193994
Recruitment Status : Recruiting
First Posted : January 18, 2022
Last Update Posted : September 29, 2022
Sponsor:
Collaborators:
King's College London
Stichting TRICALS Foundation
Information provided by (Responsible Party):
Macquarie University, Australia

Study Description
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Brief Summary:
To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Dolutegravir, Abacavir and Lamivudine Drug: Placebo Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomised in a 2:1 ratio to receive either triumeq or placebo
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis
Actual Study Start Date : February 24, 2022
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : July 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Measure plasma creatinine at 3 monthly intervals [ Time Frame: 24 months ]
    Plasma creatinine is assessed to monitor kidney function

  4. 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.

  5. Evaluate the incidence of treatment-emergent adverse events [ Time Frame: 24 months ]
    based on physical examinations and patient reported symptoms.

  6. Measure study medication discontinuation [ Time Frame: 24 months ]
    the number of participants who discontinue study medication will be assessed to assess tolerability

  7. 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.

  8. 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.

  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. 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
  7. Women of childbearing potential must have a negative serum pregnancy test at screening and baseline and be non-lactating. Women of childbearing potential are defined as females who have experienced menarche and are not surgically sterilised (e.g. hysterectomy or bilateral salpingectomy) or post-menopausal (defined as at least 1 year since last regular menstrual period).
  8. For participants taking antacids (regularly or as required), participant is willing and able to avoid taking antacids for at least 2 hours before and 6 hours after Triumeq

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
    • Creatinine clearance < 30 mL / min
    • Platelet concentration of < 100 x109 per L
    • Absolute neutrophil count of < 1x109 per L
    • Haemoglobin < 100 g/L
    • Amylase & lipase ≥ 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05193994


Contacts
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Contact: Ammar Al-Chalabi, PhD, FRCP +44 20 7848 5174 ammar.al-chalabi@kcl.ac.uk
Contact: Julian Gold, MD, FFPHM +61 411 110451 julian.gold@health.nsw.gov.au

Locations
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Australia, New South Wales
The University of Sydney - Brain and Mind Centre Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Matthew Kiernan    +61291144250    matthew.kiernan@sydney.edu.au   
Principal Investigator: Matthew Kiernan, DSc, MBBS, FRACP         
MQ Health Neurology Recruiting
North Ryde, New South Wales, Australia, 2109
Contact: Dominic B Rowe, MBBS, FRACP    +61298123720    dominic.rowe@mq.edu.au   
Principal Investigator: Dominic B Rowe, MBBS, FRACP         
Australia, Queensland
Sunshine Coast University Hospital Not yet recruiting
Birtinya, Queensland, Australia, 4575
Contact: Antony Winkel, MBBS, PhD    0752020000    Antony.Winkel@health.qld.gov.au   
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Robert Henderson    +61736468111    Robert.Henderson@health.qld.gov.au   
Principal Investigator: Robert Henderson, MBBS, PhD, FRACP         
Australia, South Australia
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: David Schultz    +61882044187    david.schultz@sa.gov.au   
Principal Investigator: David Schultz, MBBS, FRACP         
Australia, Tasmania
Launceston General Hospital Recruiting
Launceston, Tasmania, Australia, 7250
Contact: Lauren Giles    +61367776001    lauren.giles@ths.tas.gov.au   
Principal Investigator: Lauren Giles, MBBS, FRACP         
Australia, Victoria
Calvary Health Care Bethlehem Recruiting
Parkdale, Victoria, Australia, 3195
Contact: Sarah Lee    +61395962853    ChiuMunSarah.Lee@calvarycare.org.au   
Principal Investigator: Sarah Lee, MBBS, FRACP         
Australia, Western Australia
The Perron Institute Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Merrilee Needham    +61864570209    Merrilee.Needham@health.wa.gov.au   
Principal Investigator: Merrilee Needham, MBBS, PhD, FRACP         
Sponsors and Collaborators
Macquarie University, Australia
King's College London
Stichting TRICALS Foundation
Investigators
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Principal Investigator: Julian Gold, MD, FFPHM Macquarie University
More Information
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Publications:

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Responsible Party: Macquarie University, Australia
ClinicalTrials.gov Identifier: NCT05193994    
Other Study ID Numbers: LIGHTHOUSE II
2020-005069-15 ( EudraCT Number )
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is anticipated participant level data will be available as open access.
Supporting Materials: Study Protocol
Time Frame: Contact the Chief Investigators for access information.
Access Criteria: Contact the Chief Investigators for access information.

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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
Keywords provided by Macquarie University, Australia:
ALS
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Lamivudine
 Abacavir
Dolutegravir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
HIV Integrase Inhibitors
Integrase Inhibitors