Safety and Gut Microbiota Analysis of an Oral Microbiotherapy in Patients With Amyotrophic Lateral...
Amyotrophic Lateral SclerosisALSThe purpose of this pilot study is to assess the safety and tolerability of multiple doses of MaaT033 in ALS patients and to analyze the gut microbiota composition and evolution before considering a larger randomized controlled efficacy study.
A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in...
Amyotrophic Lateral SclerosisThis trial is a Phase 1a/1b, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of prosetin administered to healthy adult subjects.
Quantitative and Repetitive TMS in ALS
Amyotrophic Lateral SclerosisThe goal of this open-label pilot clinical trial is to evaluate the safety, tolerability and target engagement of accelerated, high dose continuous theta-burst stimulation (cTBS) using transcranial magnetic stimulation (TMS) in patients with ALS.
A Double-blind Randomised, Placebo-controlled Clinical Trial to Test Ambroxol Treatment in ALS
Amyotrophic Lateral SclerosisAmbroxol is a simple cough medicine that is predicted to slow ALS disease progression. This study aims to investigate if ambroxol in high doses is effective in treating ALS. This study will be carried out across 5 research sites in Australia (2 NSW, 1 VIC, 1 SA and 1 TAS), where newly diagnosed ALS patients will be asked to participate. Participation will be over a 32-week period, where they will come in for a 4-week screening, 24-week treatment, and 4-week end of study safety follow-up period. The participants will receive either the placebo or drug solution that they will take three times a day, up-dosing each week until they reach the maximum dose or highest dose they can tolerate. Throughout the study their disease progression will be assessed using tests, questionnaires, and blood biomarkers.
iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study
Amyotrophic Lateral SclerosisThis study consists of a phase 1 part and a phase 2 part. Phase 1 part: This is a phase 1, open-label, multicenter, dose escalation study to evaluate the safety and tolerability of bosutinib to determine the maximum tolerated dose(MTD) and a recommended phase 2 dose (RP2D) of bosutinib for treatment of ALS patients. Also, efficacy will be evaluated exploratory. Phase 2 part: This is an open label, multicenter, phase 2 part whose purpose is to evaluate the efficacy exploratorily and the long-term (for 24 weeks) safety of bosutinib for the treatment of ALS patients.
Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial
Amyotrophic Lateral Sclerosis (ALS)The purpose of this research is to investigate the validity of a previous clinical trial named EH301, which showed beneficial effects of anti-oxidant therapies in patients with amyotrophic lateral sclerosis (ALS). If validated by this study, providing over-the-counter anti-oxidants would be a simple, low risk, low-cost approach to significantly slow or stop the progression of ALS, for which currently no effective treatment exists. It is currently thought that oxidative stress is a major cause of ALS. The study investigators are therefore planning to expand the original scope of the previous trial by including anti-oxidants at high doses that were not previously used. All of these compounds are considered safe.
A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK)...
Amyotrophic Lateral SclerosisThe purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302 in Healthy Volunteers and...
Amyotrophic Lateral SclerosisThe first-in-human Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy volunteers and ALS participants
Study of Safety and of the Mechanism of BLZ945 in ALS Patients
Amyotrophic Lateral SclerosisIt is an open label study to evaluate safety, tolerability and brain microglia response in participants with ALS following multiple doses of BLZ945.
Triumeq in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral SclerosisTo determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo