Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT05193994
Status:
TERMINATED
Last Update Posted:
2025-07-11
First Post:
2021-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triumeq in Amyotrophic Lateral Sclerosis
Sponsor:
Macquarie University, Australia
Organization:
Study Overview
Official Title:
Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIGHTHOUSE II
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-005069-15 | EUDRACT_NUMBER | None | View |