Sulindac (HLX-0201), dose strength 1 for Fragile X Syndrome (IMPACT-FXS Trial)

"Affirmative. According to the clinicaltrials.gov portal, this research project is presently looking for participants - which it began recruiting on May 25th 2022 and updated as recently as October 26th 2022. A total of 60 patients need to be enrolled across 12 medical centers."

"This clinical trial is seeking 60 participants aged between 13 and 40 years of age, who are diagnosed with Fraxa Syndrome. In order to take part in the experiment, each subject must have given consent or assent (supported by a legal guardian), along with caregiver commitment for study requirements. Additionally, all patients should be able to understand spoken national language fluently and read/write English well enough to complete assessments; males only; minimum 45 kg weight requirement; 4+ score on Clinical Global Impression-severity scale; good overall health as judged by physical exam & lab tests; stable sertraline dose if taking medication already -"

"HLX-0206 is a common choice of medication for those suffering from acute subacromial bursitis, as well as osteoarthritis (OA), acute supraspinatus tenonitis, and gouty arthritis."

"At present, there are 4 active trials of HLX-0206 occurring in 623 cities across 2 countries. This drug was initially trialled in 2013 by Cancer Prevention Pharmaceuticals Inc., with a cohort size of 1340 patients and completed Phase 3 approval. Since then, 18,329 studies have been conducted on the medication."

"Volunteers who are over 13 and younger than 40 years old may apply to take part in this trial."

"HLX-0206 was first evaluated at the Lake Norman Hematology Oncology Specialists-Mooresville facility in 2013, leading to a total of 18329 completed trials. Presently, 4 clinical studies are actively recruiting patients, with multiple locations found in Worcester, Massachusetts."

"The current medical trial is recruiting individuals from 12 locations, including Worcester, Chicago, Aurora and additional cities. If a patient decides to take part in the experiment they should select the nearest site to eliminate travelling requirements."

"The clinical trial is currently searching for volunteers, as indicated on the information posted to clinicaltrials.gov. This experiment was initially made available to prospective participants on May 25th, 2022 and its details were most recently revised on October 26th of that same year."

"Healx Limited, the sponsor of this trial, has determined that Clinical Global Impression - I will be the main measure over a 70 day period. For safety purposes and to evaluate efficacy, additional secondary outcomes such as adverse events (AEs) and serious adverse events (SAEs), physical examination changes from baseline to Day 70, CGI-S comparisons between sulindac dose levels and KiTAP comparison between sulindac doses are also being tracked."

"Although there are some safety records which suggest HLX-0206 is a safe drug, its efficacy has yet to be demonstrated. Thus, our team at Power have assigned it a rating of 2 on the scale from 1 to 3."