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

NCT06658977 | Terminated Phase 3 DMC

• 1 other identifier: MQ2024003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis; ALS

Keywords

Lighthouse

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

  The primary endpoint of this trial is whether a patient had any drug related (definite, probable, possible) adverse events over the course of the extension trial. Tolerability is defined as the number of participants discontinuing study medication. Adverse events will be described in terms of relationship to temporary or permanent discontinuation of the study medication.

  Duration of the study plus 7 days

Study Arms (1)

Triumeq open label

EXPERIMENTAL

Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg ('Triumeq') one tablet daily

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

Interventions

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

One Triumeq tablet per day

Triumeq open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants diagnosed with ALS according to the Lighthouse II protocol who completed the Lighthouse II trial.
• Participants taking Riluzole must be on a stable dose.
• Participants taking taurursodiol supplements (TUDCA) can participate in this trial if the supplement does not contain sodium phenylbutyrate.
• 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; and women of childbearing potential must have a negative urine pregnancy test at baseline and be non-lactating.
• 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 the Triumeq dose.
• Capable of providing informed consent and complying with the trial procedures.

You may not qualify if:

• In the Principal Investigator's opinion, the participant is unlikely to be compliant with 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 had effective 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 the excipients.
• Moderate to severe hepatic impairment, as defined by local clinical guidelines.
• Participation in any other investigational drug trial or using another investigational 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)

Sponsors & Collaborators

• Macquarie University, Australia: lead

Study Sites (7)

Macquarie University, Neurology

North Ryde, New South Wales, 2109, Australia

Location

Neuroscience Research Australia (NeuRA)

Randwick, New South Wales, 2031, Australia

Location

Royal Brisbane and Womens Hospital

Herston, Queensland, 4029, Australia

Location

Flinders Medical Centre

Bedford Park, S.A., 5042, Australia

Location

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Calvary Health Care Bethlehem

Caulfield South, Victoria, 3162, Australia

Location

The Perron Institute

Nedlands, W.A., 6009, Australia

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

abacavir; Lamivudine; dolutegravir; abacavir, dolutegravir, and lamivudine drug combination

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label Extension

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: November 15, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Contact Chief Investigator for access information

Locations

AU (7)