Triumeq in Amyotrophic Lateral Sclerosis

NCT05193994 ↗

Phase 3 Terminated 419 enrolled Macquarie University, Australia King's College London · collab Stichting TRICALS Foundation · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo

Timeline

Start: 2022-02-24
Primary completion: 2025-06-30
Completion: 2025-06-30

Outcome

Outcome not reported

Stopped: “A planned interim analysis resulted in the recommendation that the trial be stopped. The results showed no benefit of Triumeq for people with ALS compared with placebo on survival, the primary outcome measure.”

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abacavir	Other / unclassified	600 mg	Oral
Subject	Dolutegravir	Other / unclassified	50 mg	Oral
Subject	Lamivudine	Other / unclassified	300 mg	Oral