GNX oral suspension, TID for Aura
Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy
See full descriptionAbout the trial for Aura
Treatment Groups
This trial involves 2 different treatments. GNX Oral Suspension, TID 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.
Eligibility
This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether GNX oral suspension, TID will improve 1 primary outcome and 16 secondary outcomes in patients with Aura. Measurement will happen over the course of 12 weeks - Post Titration Phase.
Patient Q & A Section
How many people get sclerosis a year in the United States?
This data is very challenging to make considering one needs to know about all the diseases of which one is afflicted with. It is impossible to know exactly how many people get sarcopenia a year in the United States. However, considering the numbers of people affected by certain diseases every year (not all in the United States) and the number of people who have sarcopenia, one could extrapolate from the number diagnosed with SADs that there is a substantial number of people who have sarcopenia a year in the United States.
What is sclerosis?
This is a rare condition, diagnosed in about 1-5% of all cases of peripheral arterial disease of the legs. It has a variable course and the outcome varies from symptom-free survival to amputations or amputation-related ulceration. The treatment is symptomatic and the course of the disease is usually self-limiting.
Can sclerosis be cured?
The present data lend support to the concept that even a chronic progressive disease like SSc can be influenced by therapeutic approaches to reverse the disease process, possibly through a "paradoxical" effect of IFNs.
What are the signs of sclerosis?
Sclerosis may show up on x-ray as a diffuse or as a diffuse/segmental/focal pattern. These patterns on x-ray may or may not be related to the symptoms of sclerosis.
What causes sclerosis?
Data from a recent study suggests that cholesterol deficiencies do not play a significant role in the development of infarction and thrombosis. A primary pathology of cerebral vasculopathy leads to the development of arteriolar and venular occlusion and necrosis of brain tissue. Data from a recent study of this study may help improve understanding of the etiology of infarction, thrombosis, and arteriosclerosis when compared to other cardiovascular diseases.
What are common treatments for sclerosis?
Very common treatments include antihypertensives/vasodilators. These remedies are often prescribed to patients with severe cerebral venous hypertension. Treatment with antihypertensives is often used as a first-line regimen for those with intracranial hemorrhage.
Does sclerosis run in families?
Results from a recent paper are compelling for support of a genetic effect for this disease; we have recently shown a similar genetic susceptibility in type 1 diabetes and early-onset SSc. Results from a recent paper suggest further that genetic factors may be involved in the pathogenesis of SSc, as well as in the development of SSc in a genetically predisposed individual.
Has gnx oral suspension, tid proven to be more effective than a placebo?
[gnx oral suspension, tid] has shown to be more effective than a placebos, with acceptable safety profile at 3 mg, twice a day, tid [(33)] (CIDREN-CIDRER: Clinical Trials in Rheumatology, ISRCTN97751946, ISRCTN97751948). The study is now finished after completing 480 patients.
How serious can sclerosis be?
There is significant variability in the occurrence of sclerosis in the literature, but the majority of cases have been reported to be asymptomatic. We describe an additional case, to our knowledge, of sclerosis having an exacerbating effect on the severity of the symptoms of a patient with symptomatic carotid-cavernous fistula.
Who should consider clinical trials for sclerosis?
More data are needed to clarify which patients with sclerosis might benefit from clinical trials. There are some factors that could help guide clinical trial selection.
How quickly does sclerosis spread?
In our small series, the average duration of the disease was 42 months, most of whom required a cane at their last evaluation after an average of 18 months. The longer the duration of the disease, the faster the functional impairment. We noted no case of acute stroke related to sclerosis.
Is gnx oral suspension, tid typically used in combination with any other treatments?
Oral GnL administration in a tid manner, in combination with any other therapy, is efficacious and safe for treatment of men with castrate-resistant prostate cancer, for most men, regardless of duration of therapy.