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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06658977




Registration number
NCT06658977
Ethics application status
Date submitted
23/10/2024
Date registered
26/10/2024

Titles & IDs
Public title
RolloverTreatment with Triumeq for People with ALS Following the Lighthouse II Trial
Scientific title
Open Label Rollover Study of Triumeq in Patients with Amyotrophic Lateral Sclerosis (ALS) Following the Lighthouse II Trial
Secondary ID [1] 0 0
MQ2024003
Universal Trial Number (UTN)
Trial acronym
Lighthouse III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis 0 0
ALS 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)

Experimental: Triumeq open label - Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg ('Triumeq') one tablet daily


Treatment: Drugs: Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)
One Triumeq tablet per day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Timepoint [1] 0 0
Duration of the study plus 7 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,S.A.TAS,VIC,W.A
Recruitment hospital [1] 0 0
Macquarie University, Neurology - North Ryde
Recruitment hospital [2] 0 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment hospital [3] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [6] 0 0
Calvary Health Care Bethlehem - Caulfield South
Recruitment hospital [7] 0 0
The Perron Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
3162 - Caulfield South
Recruitment postcode(s) [7] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Macquarie University, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Julian Gold, MD, FFPHM
Address 0 0
Country 0 0
Phone 0 0
+61 411 110451
Fax 0 0
Email 0 0
julian.gold@health.nsw.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Contact Chief Investigator for access information

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Available to whom?
Contact Chief Investigator for access information
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06658977