RolloverTreatment With Triumeq for People With ALS Following the Lighthouse II Trial
Megadott ok: This is a rollover study following the Lighthouse II trial; it was scheduled to stop when the LH II trial was stopped/completed. The LH II trial has been prematurely terminated so, likewise, this study has also now been stopped.
Key facts
- Where
- Bedford Park, Caulfield South, Herston, Launceston, Nedlands, North Ryde és Randwick, AusztráliaSee the 7 sites
- Phase
- 3. fázis
Where in Ausztrália
- Flinders Medical CentreBedford Park, AusztráliaNo longer taking part
- Calvary Health Care BethlehemCaulfield South, AusztráliaNo longer taking part
- Royal Brisbane and Womens HospitalHerston, AusztráliaNo longer taking part
- Launceston General HospitalLaunceston, AusztráliaNo longer taking part
- The Perron InstituteNedlands, AusztráliaNo longer taking part
- Macquarie University, NeurologyNorth Ryde, AusztráliaNo longer taking part
- Neuroscience Research Australia (NeuRA)Randwick, AusztráliaNo longer taking part
Trial details
- Who runs it
- Macquarie University, Australia
- Trial code
- NCT06658977
- Record updated
- 2025. június 8.
- Original description
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.Read full original descriptionShow less
Open Label Rollover Study of Triumeq in Patients With Amyotrophic Lateral Sclerosis (ALS) Following the Lighthouse II Trial
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.
Inclusion: 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: In the Principal Investigator's opinion, the participant is unlikely to be compliant with the study drug dosing; Participation in any other investigational drug trial or using another investigational drug within 5 half-lives of that drug; Taking medication contraindicated with Triumeq: Dofetilide or Fampridine (dalfampridine); 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; Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness; People who are HLA-B*5701 positive; Use of NIV ≥22 h per day or having a tracheostomy.