Clinical trial NCT06658977: RolloverTreatment With Triumeq for People With ALS Following the Lighthouse II Trial
Official title: Open Label Rollover Study of Triumeq in Patients With Amyotrophic Lateral Sclerosis (ALS) Following the Lighthouse II Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Amyotrophic Lateral Sclerosis
ALS
Keywords: Lighthouse
Lead sponsor: Macquarie University, Australia
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Extension
Primary purpose: TREATMENT

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.

Detailed description: Treatment options for ALS are very limited and there is a high unmet need for effective treatments. Triumeq targets a known neuron toxic pathway and is currently under investigation in a double blind placebo controlled trial, Lighthouse II. This study will be open to participants who took part in, and were still taking the study drug when they completed the Lighthouse II trial, in Australia and New Zealand.

The nature of the target and the mechanism of action of Triumeq are well understood. Participation in this rollover study is concurrent with standard of care, so participants are not limited in their use of therapies.

Participants will be assessed for adverse events, discontinuation of study medication, survival, measures of daily functioning, plus biomarker assessments of blood and urine samples.

Participant contacts may be face to face, or remote, and will be at 3 monthly intervals until approx December 2026 by which time it is anticipated the results of the Lighthouse II study will be available.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
timeFrame: Duration of the study plus 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: North Ryde
country: Australia
facility: Macquarie University, Neurology
state: New South Wales
city: Randwick
country: Australia
facility: Neuroscience Research Australia (NeuRA)
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Womens Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: S.A.
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Caulfield South
country: Australia
facility: Calvary Health Care Bethlehem
state: Victoria
city: Nedlands
country: Australia
facility: The Perron Institute
state: W.A.
Study officials:
References: