Researchers will be recruiting 90 people across NSW, QLD, SA, WA and VIC who meet the criteria for enrolment to participate in the TEALS Study - a multi-centre Phase 2 clinical trial to investigate the safety, tolerability and effectiveness of a drug called Tecfidera in people with MND (The study to Assess the Efficacy and Safety of Tecfidera in Patients with Amyotrophic Lateral Sclerosis - TEALS, Study ID ACTRN12618000534280).
(Source: National Health and Medical Research Council)
Key inclusion criteria:
1. Male and female patients aged 18 to 85 years at the time of the Screening Visit. 2. Able to provide informed consent and comply with study procedures. 3. Sporadic ALS diagnosed as definite, probable, or possible according to the Awaji criteria as determined by a neurologist subspecializing in ALS. 4. Disease duration at recruitment less than 24 months from diagnosis. 5. Patient must have the results of magnetic resonance imaging scan of brain and spinal cord undergone within 2 years (24 months) prior to the Screening Visit. 6. Forced vital capacity >60% of predicted value as adjusted for gender, height, and age at the Screening Visit. 7. Must be on a stable dose of riluzole for at least 30 days prior to the Screening Visit. 8. Patient who has established care with a neurologist at 1 of the 5 specialised ALS clinics involved in the study and will maintain this clinical care throughout the study. 9. If a patient is referred from a third party (neurologist or a State based ALS organisation) they should be willing to transfer care to the neurologist participating in the study. 10. Patients may participate in clinical registries, but will be excluded if they are participating in a clinical study involving an alternative investigational treatment. 11. Women of childbearing potential must have a negative urine pregnancy test at screening and Baseline, and be surgically sterile or postmenopausal, or using highly effective methods of contraception throughout the study and for 30 days after the last dose of IP.
Minimum age18 Years
Maximum age 85 Years
Gender Both males and females
Key exclusion criteria
1. Dependence on mechanical ventilation at the time of screening. 2. Gastrostomy at the time of Screening/Baseline Visit. If the patient has a gastrostomy tube inserted post randomisation they will be allowed to continue in the study. 3. Participation in any other IP study or using an IP (within 12 weeks prior to screening). 4. Known hypersensitivity to Tecfidera or any excipients in this product. 5. Presence of a monogenic cause of ALS (e.g. known mutation in superoxide dismutase-1 (SOD1), expansion in c9orf72 etc.). 6. Taking immunosuppressive medications. 7. Positive test for human immunodeficiency virus (HIV), hepatitis B (+HbsAg), or hepatitis C. 8. Presence of any of the following clinical conditions at the time of screening: -Unstable medical disease (such as unstable angina, heart failure, chronic obstructive pulmonary disease, liver disease or renal disease), or active infectious diseases (such as hepatitis B or C or tuberculosis), or current malignancy. -Unstable psychiatric illness defined as psychosis or untreated major depression within 90 days of the Screening Visit. This exclusion criteria is based on a prior psychiatric diagnosis that is unstable as determined by the patient’s treating Psychiatrist. -Dementia as previously diagnosed by a medical practitioner. 9. Safety Laboratory Criteria at the Screening Visit: -Alanine aminotransferase >3 × the upper limit of normal (ULN). -Total bilirubin, lactate, triglycerides, amylase, or lipase >2 × the ULN. -Patient has impaired renal function defined as creatinine clearance of <40 mL/min via Cockroft Gault method. -Absolute neutrophil count of <2 × 109/L. -Absolute lymphocyte count of <0.5 × 109/L. -Platelet concentration of <100 × 109/L. -Haemoglobin <100 g/L. 10. Female patients who are pregnant or lactating, or intend to become pregnant during the study period.
Full trial listing: https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12618000534280
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