The patients to be enrolled in this study must meet the following inclusion criteria:Able to understand and give written informed consent. Male or female patients aged 40 years or greater (inclusive) and less than 80 years of age at the time of ALS diagnosis. Patients whose conditions are defined as possible or probable or definite ALS per the updated Awaji criteria as determined by a neurologist subspecialising in ALS (eg, the principal investigator by study site). Stable dosing of riluzole over the prior 30 days. Disease duration less than or equal to 24 months from symptom onset at the time of screening. Forced vital capacity ≥60% of predicted value as adjusted for gender, height and age at the screening visit. Patient who has established care with a neurologist at one of the specialised ALS clinics involved in the study and will maintain this clinical care throughout the study. If a patient is referred from a third party (neurologist or a state-based ALS organisation), they must be willing to transfer care to the neurologist participating in the study.
| Patients will be excluded from the study if they meet any of the following criteria:At screening patients who use, or in the investigator’s judgement will be imminently dependent on: Non-invasive ventilation ≥22 hours per day. Tracheostomy. Wheelchair dependency.
Note: If the patient requires non-invasive ventilation or wheelchair dependence postrandomisation, they will be allowed to continue in the study.Patients with familial ALS (eg, 2 or more family members with ALS or motor neurone disease). Patients with a history of carpal tunnel syndrome, polyneuropathy or in the investigators judgement diseases that could induce polyneuropathy and interfere with electromyography (EMG) recordings. Patients with too severe atrophy of the abductor digiti minimi, abductor pollicis brevis, biceps brachii or tibialis anterior muscles in the least clinically affected hand and leg, respectively, to allow for reliable EMG recordings. Patient with a history of significant other major medical conditions based on the investigator’s judgement. Based on the investigator’s judgement, patients who may have difficulty complying with the protocol and/or any study procedures. Patient with clinically significant abnormalities in haematology, blood chemistry, ECG or physical examination not resolved by the baseline visit which according to investigator can interfere with study participation. Patients with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function, or those with low platelet counts (<150 x 109 per litre) or eosinophilia (absolute eosinophil count of ≥500 eosinophils per microlitre) at screening. Patient participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter). Females who are pregnant or nursing or who plan to get pregnant during the course of this clinical trial or within 6 months of the end of this trial. Females of childbearing potential, or men, who are unwilling or unable to use accepted methods of birth control. Active inflammatory condition or autoimmune disorder. Positive screen for drugs of abuse. History of gold allergy. Patient is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator.
|