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

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)