NCT05193994

Triumeq in Amyotrophic Lateral Sclerosis

Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 419 (actual)
• Sponsor: Macquarie University, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Dolutegravir, Abacavir and Lamivudine	Dolutegravir 50mg, Abacavir 600mg and Lamivudine 300mg.
DRUG	Placebo	Matching placebo.

Timeline

• Start date: 2022-02-24
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-01-18
• Last updated: 2025-07-11

Locations

28 sites across 8 countries: Australia, Ireland, Netherlands, New Zealand, Slovenia, Spain, Sweden, United Kingdom