Study Purpose:
To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placeboStudy Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Dolutegravir, Abacavir and Lamivudine, Placebo
Placebo:
Yes
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Julian Gold, MD, FFPHM, Macquarie University
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Ammar Al-Chalabi, PhD, FRCP / email hidden; JavaScript is required / +44 20 7848 5174
Full Study Summary:
Study Sponsor:
Macquarie University, Australia
Estimated Enrollment:
390
Estimated Study Start Date:
02 / 24 / 2022
Estimated Study Completion Date:
07 / 01 / 2026
Posting Last Modified Date:
09 / 29 / 2022
Date Study Added to neals.org:
01 / 18 / 2022
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion Criteria:1. Age ≥ 18 years at the time of screening
2. Diagnosis of ALS according to the Gold Coast Criteria
3. Capable of providing informed consent and complying with trial procedures
4. TRICALS risk profile > -6.0 and < -2.0
5. Those taking Riluzole must be on a stable dose for at least 30 days prior to the baseline visit or must have stopped taking Riluzole at least 30 days prior to the baseline visit
6. 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. Highly effective methods of birth control are those with a failure rate of < 1% per year when employed consistently and correctly, e.g. Combined (oestrogen and progestogen containing) hormonal contraception or progestogen-only hormonal contraception
7. Women of childbearing potential must have a negative serum pregnancy test at screening and baseline and be non-lactating. Women of childbearing potential are defined as females who have experienced menarche and are not surgically sterilised (e.g. hysterectomy or bilateral salpingectomy) or post-menopausal (defined as at least 1 year since last regular menstrual period).
8. For participants taking antacids (regularly or as required), participant is willing and able to avoid taking antacids for at least 2 hours before and 6 hours after Triumeq
Exclusion Criteria:
1. People who are HLA-B*5701 positive
2. Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients
3. Safety Laboratory Criteria at screening:
- ALT ≥ 5 times upper limit of normal (ULN)
- AST ≥ 3 times ULN
- Bilirubin ≥ 1.5 times ULN
- Creatinine clearance < 30 mL / min
- Platelet concentration of < 100 x109 per L
- Absolute neutrophil count of < 1x109 per L
- Haemoglobin < 100 g/L
- Amylase & lipase ≥ 2 times ULN
- Lactate ≥ 2 times ULN
4. Moderate to severe hepatic impairment, as defined by local clinical guidelines
5. Presence of HIV antibodies at screening
6. Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C
7. Presence of Hepatitis B core or surface antigen at screening
8. Participation in any other investigational drug trial or using investigational drug within 30 days prior to screening
9. Use of NIV ≥22 h per day or having a tracheostomy
10. Edaravone dose within 30 days prior to screening. Edaravone is approved by the FDA and in Japan, but remains an investigational product in Europe and Australia
11. Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness
12. Taking medication contraindicated with Triumeq: Dofetilideor Fampridine (dalfampridine)
The University of Sydney - Brain and Mind Centre | Recruiting
Matthew Kiernan / +61291144250 / email hidden; JavaScript is required
Principal Investigator : Matthew Kiernan, DSc, MBBS, FRACP
Camperdown, New South Wales
2050
Australia
MQ Health Neurology | Recruiting
Dominic B Rowe, MBBS, FRACP / +61298123720 / email hidden; JavaScript is required
Principal Investigator : Dominic B Rowe, MBBS, FRACP
North Ryde, New South Wales
2109
Australia
Sunshine Coast University Hospital | Not yet recruiting
Antony Winkel, MBBS, PhD / 0752020000 / email hidden; JavaScript is required
Birtinya, Queensland
4575
Australia
Royal Brisbane and Women's Hospital | Recruiting
Robert Henderson / +61736468111 / email hidden; JavaScript is required
Principal Investigator : Robert Henderson, MBBS, PhD, FRACP
Herston, Queensland
4029
Australia
Flinders Medical Centre | Recruiting
David Schultz / +61882044187 / email hidden; JavaScript is required
Principal Investigator : David Schultz, MBBS, FRACP
Bedford Park, South Australia
5042
Australia
Launceston General Hospital | Recruiting
Lauren Giles / +61367776001 / email hidden; JavaScript is required
Principal Investigator : Lauren Giles, MBBS, FRACP
Launceston, Tasmania
7250
Australia
Calvary Health Care Bethlehem | Recruiting
Sarah Lee / +61395962853 / email hidden; JavaScript is required
Principal Investigator : Sarah Lee, MBBS, FRACP
Parkdale, Victoria
3195
Australia
The Perron Institute | Recruiting
Merrilee Needham / +61864570209 / email hidden; JavaScript is required
Principal Investigator : Merrilee Needham, MBBS, PhD, FRACP
Nedlands, Western Australia
6009
Australia