{"id":6911,"date":"2018-06-07T12:10:16","date_gmt":"2018-06-07T12:10:16","guid":{"rendered":"https:\/\/laforcedmd.com\/?p=6911"},"modified":"2022-05-03T18:15:56","modified_gmt":"2022-05-03T18:15:56","slug":"recruiting-participants-here-in-canada-laforcedmd","status":"publish","type":"post","link":"https:\/\/laforcedmd.com\/en\/recruiting-participants-here-in-canada-laforcedmd\/","title":{"rendered":"Recruiting participants here in Canada"},"content":{"rendered":"<p>&nbsp;<\/p>\n<h4>Sarepta Therapeutics is recruiting DMD patients that have out-of-frame deletion mutations in dystrophin that may be treated by skipping exon 45 or exon 53 for its ESSENCE study.<\/h4>\n<p>&nbsp;<\/p>\n<h3>Purpose of the ESSENCE Study<\/h3>\n<p><span style=\"font-weight: 400;\">Sarepta is recruiting for Duchenne muscular dystrophy (DMD) patients with deletion mutations amenable to exon 45 or exon 53 skipping.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The purpose of this Phase III research study is to evaluate the safety and effectiveness of\u00a0<\/span><span style=\"font-weight: 400;\">SRP-4045 and SRP-4053 in boys with DMD, who have a deletion that is potentially responsive or amenable to exon 45 or exon 53 skipping.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">ESSENCE is a randomized, placebo-controlled study. Each study participant will be randomly assigned to receive either active study drug (SRP-4045 or SRP-4053, depending on his deletion type) or placebo. Placebo is made to look just like the active study drug, but it will not contain any active substance. Researchers use a placebo to see if the active study drug works and to see how safe and effective it is compared to not taking anything. This trial design is the best way to get a clear answer about the safety and effectiveness of a new drug and is usually required by regulatory authorities in the approval process for a drug.<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3>Who may be able to participate in the ESSENCE study?<\/h3>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Boys with DMD, 7 to 13 years old who can walk<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Boys having a genetic test that shows they have a deletion that may be treated by skipping exon 45 or 53*<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Boys that have been on a stable dose of corticosteroids (e.g. prednisone or deflazacort) for at least six months<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Stable lung (breathing) and heart function<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Why should I consider participating in this study?<\/h3>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Access to an investigational therapy <\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Access to highly experienced clinicians with strong expertise in treating DMD<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Opportunity to become more familiar with what participation in a clinical study entails<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Opportunity to help others by contributing to medical research that may accelerate <\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Two hospitals are participating in this trial in Canada:<\/h3>\n<p><b>Alberta &gt; <\/b>Alberta Children\u2019s Hospital<\/p>\n<p><span style=\"font-weight: 400;\"><strong>Principal Investigator:<\/strong> Jean Mah, MD<\/span><\/p>\n<p><strong>Contact: <\/strong><a href=\"mailto:tiffany.haig@albertahealthservices.ca\"><span style=\"font-weight: 400;\">tiffany.haig@albertahealthservices.ca<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\"> \u00a0\u00a0<\/span><\/p>\n<p><b>Ontario &gt;\u00a0<\/b>London Health Sciences Centre<\/p>\n<p><span style=\"font-weight: 400;\"><strong>Principal Investigator:<\/strong> Craig Campbell, MD <\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>Contact:<\/strong> <\/span><a href=\"mailto:gina.bhullar@lhsc.on.ca\"><span style=\"font-weight: 400;\">gina.bhullar@lhsc.on.ca<\/span><\/a><\/p>\n<h3><\/h3>\n<p><b>More trial sites: <\/b><a href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/study\/NCT02500381?term=NCT02500381&amp;rank=1&amp;show_locs=Y#locn\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">clinicaltrials.gov<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<h3>What is Exon Skipping<\/h3>\n<p>Mutations in the dystrophin gene are one cause of DMD. Most commonly, one or more exons (a portion of a gene) are missing, and the remaining exons don\u2019t fit together correctly. (Think of a zipper that doesn\u2019t work properly, because teeth are missing.)<\/p>\n<p>Because of this error, cells cannot make the dystrophin protein that muscles need to work properly. Without it, muscle cells become damaged and, over time, are replaced with scar tissue and fat.<\/p>\n<p>To fix the broken genetic machinery, scientists are developing drugs that skip over parts that contain missing or defective exons. In this way, the machinery can produce a less imperfect dystrophin protein, which may improve muscle function in children with exon mutations.<\/p>\n<p><span style=\"font-weight: 400;\">Sarepta investigational therapies in the ESSENCE study use a technique referred to as exon skipping. Skipping a specific exon next to the mutation is intended to allow the body to make a shortened form of the dystrophin protein.<\/span><\/p>\n<p>&nbsp;<\/p>\n<h3>About DMD<\/h3>\n<p><span style=\"font-weight: 400;\">Duchenne muscular dystrophy (DMD) is a disease that almost exclusively affects boys and whose incidence is 1 in 3,500. It is extremely rare that Duchenne muscular dystrophy (DMD) will affect girls. Those affected are usually diagnosed around the age of five, but symptoms may be visible from early childhood. It is a degenerative disease of the muscles caused by a genetic mutation. The Duchenne muscular dystrophy (DMD) \u2013 for which no treatment is currently available \u2013 directly affects skeletal muscles. Without treatment, the consequences of the disease are dire for those afflicted and their families.<\/span><\/p>\n<p>Disclaimer:\u00a0<i><span style=\"font-weight: 400;\">Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors.<\/span><\/i><\/p>\n<p>&nbsp;<\/p>\n<h3>More about ESSENCE<\/h3>\n<p><b>Brochure<\/b><strong>: <\/strong><a href=\"https:\/\/www.sarepta.com\/sites\/default\/files\/pdfs\/4045-301_Brochure_MRC%20Approved_FINAL_single_pages%5B2%5D.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">sarepta.com\/Brochure.pdf<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\"><strong>For more information, contact:<\/strong> trialinfo@sarepta.com Visit www.sarepta.com for updates on Sarepta&#8217;s clinical studies<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>ESSENCE:<\/strong> <\/span><a href=\"https:\/\/essencetrial.com\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">essencetrial.com<\/span><\/a><\/p>\n<p><strong>ESSENCE clinical trial information:<\/strong> <a href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02500381?term=NCT02500381&amp;rank=1\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">clinicaltrials.gov\u00a0<\/span><\/a>\u00a0#NCT02500381<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; Sarepta Therapeutics is recruiting DMD patients that have out-of-frame deletion mutations in dystrophin that may be treated by skipping exon 45 or exon 53 for its ESSENCE study. &nbsp; Purpose of the ESSENCE Study Sarepta is recruiting for Duchenne muscular dystrophy (DMD) patients with deletion mutations amenable to exon 45 or exon 53 skipping. [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6927,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12,18],"tags":[],"class_list":["post-6911","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-treatments"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Recruiting participants here in Canada - La Force DMD<\/title>\n<meta name=\"description\" content=\"Recruiting patients with Duchenne muscular dystrophy (DMD) with deletion mutations amenable to exon 45 or exon 53 skipping for a clinical trial.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/laforcedmd.com\/en\/recruiting-participants-here-in-canada-laforcedmd\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Recruiting participants here in Canada - 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