This trial is evaluating whether Solanezumab will improve 1 primary outcome and 8 secondary outcomes in patients with Overinclusion. Measurement will happen over the course of Baseline, Week 240.
This trial requires 1150 total participants across 2 different treatment groups
This trial involves 2 different treatments. Solanezumab 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.
"There exists a need for new studies to test the evidence for overinclusion in the medical literature, as it is clear that many studies that fail to find an effect have methodological flaws that impede their interpretation." - Anonymous Online Contributor
"About 1 million people in the United States experience overinclusion at least once a year. More than 40% of these patients continue experiencing the disorder at least a few times a year for more than 12 months. Some people never get overinclusion-induced tic disorders. The incidence of these disorders increases with age." - Anonymous Online Contributor
"When a clinical picture including abnormal beliefs and symptoms is seen in a patient, a detailed history should be taken to gain an accurate history of the person's thoughts and behaviours that may help with their diagnosis. The signs of excessive beliefs about non-existent illnesses, or "overinclusion" should be noted and investigated further." - Anonymous Online Contributor
"Most patients with this condition were managed with nonoperative measures. Lateral retraction was the most effective strategy, and patients achieved favorable results with nonsurgical intervention only, especially with less aggressive procedures. The less invasive and non operative options for this condition should be further evaluated." - Anonymous Online Contributor
"Although the majority of women who want a second child are well-informed and self-determine their own ovulation, infertility and contraception treatments, in our study, about two thirds did not consult their [doctor or midwife] about the possibility or benefits of contraception and almost one quarter (17) did not use a contraceptive method as stated." - Anonymous Online Contributor
"Within the bounds of this study, it will help patients understand the various options available to them for treatment and the risk of treatment failure." - Anonymous Online Contributor
"Results from a recent paper indicate that PFCs overinclusion is associated with specific developmental and behavioral abnormalities, including an increased likelihood of social problem behaviors." - Anonymous Online Contributor
"[As a result of multiple questions about solanezumab in clinical trials, we can only speculate for sure that it may help a small number of patients with high-grade, advanced choroidal neovascularization and macular oedema when treatment with an anti-VEGF regimen fails or has side effects that make it no longer an option] (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324983/overview/). However, patients may be eligible based on baseline data and signs and symptoms." - Anonymous Online Contributor
"- I. Vascular disease\n- II. Other causes of stroke\n- III. Myocardial infarction\n- IV. Deep venous thrombosis\n- V. Pericarditis\n- VI. Other vascular disease\n- VII. Infective or parasitic diseases\n- VIII. Other vascular disease\n- IX. Congenital heart disease\nThe overall results of the trial were very good considering its small sample size." - Anonymous Online Contributor
"Solanezumab is currently approved in the United States only for the treatment of moderate-to-severe plaque psoriasis. The drug's label does not contain any contraindications for patients with Crohn's disease, a known risk factor for death, as is also true for patients with a previous recurrence of Crohn's disease (i.e., Crohn's relapse). It is very conceivable that other indications may be discovered with further followup of this drug in patients with Crohn's disease, and thus more patients might be eligible for enrollment in future trials." - Anonymous Online Contributor
"Although enrollment in clinical studies for overinclusion is a growing issue in the research community, a comprehensive assessment of all clinical trial data must evaluate the scientific merit of all potential participants. The most accurate assessment can be made by assessing whether potential research participants can be accurately ascertained for enrollment by applying the inclusion and exclusion criteria that are specified for a study." - Anonymous Online Contributor
"Overinclusion is an objective measure of uncertainty regarding the clinical significance of a test result. It may serve as a useful decision aid in making decisions concerning whether to repeat a specific test using the modified SIR criteria for further clinical analysis." - Anonymous Online Contributor