This trial is evaluating whether AMX0035 will improve 3 primary outcomes and 6 secondary outcomes in patients with Amyotrophic Lateral Sclerosis. Measurement will happen over the course of 48 weeks.
This trial requires 600 total participants across 2 different treatment groups
This trial involves 2 different treatments. AMX0035 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
"Signs of sclerosis include muscle atrophy, muscle wasting, muscle weakness, reduced or zero muscle tone, elevated muscle enzyme levels, and/or high blood markers of inflammation. Symptoms of sclerosis are typically first seen in late middle to old age." - Anonymous Online Contributor
"The cause of sclerosis is unknown and the relationship of sclerosis to other diseases is unclear. However, some studies suggest it may be associated with drug use or diseases of the digestive system and with the use of certain medications. The exact cause of the white matter lesion is also unknown." - Anonymous Online Contributor
"The number of people with SCI rises dramatically in the years following the initial trauma. At age 19, only 0.4% of men were estimated to have SCI. At age 44, this rises to 7.7% for men and 4.9% for women. As the population ages, it is predicted that there will be 7.9 million SCI patients by 2030." - Anonymous Online Contributor
"In the United States 10 to 25% of patients continue to have disabling symptoms after [brain] sclerosis. Although there are a number of well-studied treatments for Alzheimer's disease, no treatment currently exists that can cure an actual case of sclerosis. Nevertheless, the use of specific DMTs seems to help reduce the frequency of seizures and stroke-related complications, but it does not cure the condition. The fact that the brain controls the central and peripheral nervous systems, and that the brain controls the muscles that control the brain, makes the brain difficult to treat with conventional treatments for physical disorders." - Anonymous Online Contributor
"Sclerosis is a long-term, chronic inflammatory condition of the blood vessels and brain tissue that leads to a decrease in blood flow to the brain and parts of the body. There are two kinds of sclerosis. Primary sclerosis is caused by an inflammatory condition, and secondary sclerosis is created by several medications and environmental factors." - Anonymous Online Contributor
"Physical therapy is sometimes used for improving posture, range of motion, and muscle strength; and stretching is used to alleviate discomfort. In addition, lifestyle changes are recommended as a strategy to control hypertension or to preserve weight. Surgery is used in cases of severe disease, recurrent attacks, or refractory pain." - Anonymous Online Contributor
"The data suggest that amx0035 is more effective than a placebo. This could probably be attributed to the higher doses used in the previous studies, where they were administered at a much lower dose per day compared with the present study where the drug has been administered at a higher dose. Additional studies are needed to confirm this finding and to explore the reason for this statistically significant difference." - Anonymous Online Contributor
"The primary cause of PSS is unknown and, in particular, whether a causal link exists between PSS and systemic ANCA positivity. Because the number of PSS cases in the reported ANCA-positive PSS series is low, it is conceivable that the presence of ANCA indicates secondary autoimmune mechanisms, rather than a primary autoimmune process." - Anonymous Online Contributor
"At presentation, the majority of patients had sclerosis occurring during mid-life to middle-aged decades of their lives. There is no significant difference in sclerotic disease age according to gender with males at the most advanced sclerotic stage at 65.3 years of age and females at 56.2 years of age. There are also no differences in age of disease onset according to race, ethnicity, or disease duration." - Anonymous Online Contributor
"Amx0035 in combination with either etanercept, adalimumab, or ustekinumab was effective in patients with ankylosing spondylitis. Data from a recent study should be prospectively determined in randomized, placebo-controlled clinical trials." - Anonymous Online Contributor
"This is a new report looking at the indications that amx0035 is licensed to treat; this may be helpful in identifying and managing patients' pain, improving functional skills, and managing co-morbid conditions." - Anonymous Online Contributor
"amx0035 is a novel, effective and safe therapeutic drug for adults over the age of 18 who have persistent or recurrent symptoms associated with a form of lung disease, including bronchiolitis and asthma. amx0035 is also approved in Canada for patients with the following two specific forms of chronic obstructive pulmonary disease: idiopathic pulmonary fibrosis and asthma in patients who are over the age of 18. As a result of these developments, amx0035 is rapidly gaining interest from a number of medical centres across Europe, Latin America and North America." - Anonymous Online Contributor