Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Triumeq
Product Name: Triumeq
Pharmaceutical Form: Capsule
INN or Proposed INN: Dolutegravir
CAS Number: 1051375/19/5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Stichting TRICALS Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years at the time of screening 2. Diagnosis of ALS according to the Gold Coast Criteria (Please see Table 1 of Shefner et al Clinical Neurophysiology 2020, also available in Appendix 2) 3. Capable of providing informed consent and complying with trial procedures 4. TRICALS risk profile > -6.0 and =65 years) yes F.1.3.1 Number of subjects for this age range 270
Exclusion criteria
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, with clinical indicators of liver disease Creatinine clearance < 30 mL / min Platelet concentration of < 100 x109 per L Absolute neutrophil count of < 1x109 per L Haemoglobin < 100 g/L Amylase = 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) 13. Taking Tofersen within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if Triumeq improves survival in patients with ALS;Secondary Objective: To determine if Triumeq improves secondary outcomes and selected biomarkers compared with placebo.;Primary end point(s): The primary endpoint is overall survival, defined as time to mortality from any cause ;Timepoint(s) of evaluation of this end point: Up to Month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To assess the effect of Triumeq versus placebo on a combined assessment of survival and measures of daily functioning (CAFS) 2. To assess the effect of Triumeq versus placebo on measures of daily functioning 3. To assess the effect of Triumeq versus placebo on respiratory function 4. To assess the effect of Triumeq versus placebo on plasma creatinine 5. To assess the effect of Triumeq versus placebo on the time to reach advanced disease stages 6. To evaluate the safety of Triumeq administered orally to participants with ALS 7. To evaluate the tolerability of Triumeq administered orally to participants with ALS 8. To assess the effect of Triumeq versus placebo on change in cognitive functioning 9. To assess the effect of Triumeq versus placebo on change in quality of life 10. To collect research blood and urine samples for post-trial explanatory analyses; markers will be included e.g. urinary P75ECD, plasma neurofilament light and heavy chain, HERV-K, and genotyping ;Timepoint(s) of evaluation of this end point: Up to Month 24 | — |
Countries
Australia, Ireland, Netherlands, Slovenia, Spain, United Kingdom
Contacts
Public ContactOperations office
Stichting TRICALS Foundation
Outcome results
None listed