{"id":3586,"date":"2022-09-05T12:42:55","date_gmt":"2022-09-05T12:42:55","guid":{"rendered":"http:\/\/wordpress.mytomorrows.com\/?p=3586"},"modified":"2024-02-27T13:26:34","modified_gmt":"2024-02-27T13:26:34","slug":"10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials","status":"publish","type":"post","link":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/patients\/10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials\/","title":{"rendered":"10 Commonly Asked Questions about Duchenne Muscular Dystrophy Clinical Trials"},"content":{"rendered":"
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Participating in a clinical trial takes courage, time, sacrifice, and commitment \u2014 but it may also be an opportunity to potentially access a drug many years before it is available to the public.<\/p>\n

There are many unknowns when it comes to enrolling in a Duchenne Muscular Dystrophy clinical trial, and parents often have many concerns and questions. I personally understand this because I have lived through this experience.<\/p>\n

One of the most important things to remember is that clinical trials are research. Clinical trials are research studies that evaluate drugs in development. When a new drug is being developed, it must be tested extensively in order to evaluate its safety and effectiveness. It\u2019s important to remember that there are no guarantees, and parents should understand that clinical trials are to be considered as research.<\/p>\n

What we do know, understand, and accept, is that clinical trials are necessary to propel science and move the proverbial needle forward. Clinical trials are a crucial part of developing new drugs to treat patients with Duchenne and other conditions.<\/p>\n

My son, Billy, who was diagnosed with Duchenne muscular dystrophy at age four, enrolled in a clinical trial at age 10. After more than five years in the clinical trial, the drug was approved by the FDA. Billy remains on the drug and is in his 12th year of receiving treatment.\u00a0He turned 21 in January, and I shared our journey in this blog.<\/p>\n

Parents who have a child with Duchenne often want to read about current research on Duchenne muscular dystrophy and may want to search for Duchenne clinical trials. Clinical trials are often complex to understand, and parents understandably have many questions. My blog discusses some of the things you may want to contemplate when considering a Duchenne clinical trial for your child.<\/p>\n

1) What is Duchenne muscular dystrophy?<\/strong><\/h3>\n

Muscular dystrophy is a progressive disease that causes weakness and wasting away of the body\u2019s muscles. There are nine major types of muscular dystrophy. Duchenne muscular dystrophy is the most common and progressive type in children. It predominantly affects boys because it is an\u00a0X-recessive linked condition.<\/p>\n

2) What is a Duchenne muscular dystrophy clinical trial?<\/strong><\/h3>\n

A clinical trial is a research study to evaluate an investigational drug\u2019s safety and efficacy. There is a lot of current research on Duchenne muscular dystrophy, and there are currently\u00a0many clinical trials and studies in progress\u00a0seeking to find new and efficient means to treat Duchenne. Clinical trials help to advance science and medical innovation by bringing new treatment options to patients. Here is more information about\u00a0Duchenne muscular dystrophy clinical trials.<\/p>\n

3) Will my child get a placebo, and will my child\u2019s function decline if given a placebo instead of the actual experimental drug?<\/strong><\/h3>\n

Every child is different, and this should be discussed with your child\u2019s pediatric neurologist.<\/p>\n

A placebo is designed to look the same as the drug that is being evaluated in a clinical trial, but it does not actually contain any medicine.<\/p>\n

It\u2019s important to keep in mind that enrolling in a clinical trial doesn\u2019t mean that your child will necessarily receive the new treatment. Many trials are randomized controlled clinical trials. In a randomized controlled clinical trial, patients are randomly assigned to either the group that receives the new treatment or the group that gets the placebo \u2014 a process that is called randomization. Randomization helps researchers evaluate the new treatment with the standard treatment without their assumptions or bias interfering.<\/p>\n

Some trials are double-blinded, meaning that neither the principal investigator nor the patient knows if they are receiving the actual drug or the placebo. This also aims to ensure that information during the clinical trial is collected objectively without bias.<\/p>\n

At a certain point in some clinical trials, patients who were getting a placebo may begin getting the investigational drug.<\/p>\n

4) What types of drugs and therapies are in development in clinical trials for Duchenne muscular dystrophy? How can I search for Duchenne muscular dystrophy clinical trials?<\/strong><\/h3>\n

Parents are often interested in the current research on Duchenne muscular dystrophy and Duchenne clinical trials. myTomorrows offers\u00a0a free service to help parents find Duchenne muscular dystrophy clinical trials<\/a>. If a family and their physician decide they want to enroll in a clinical trial, we can try to assist them.<\/p>\n

When parents begin searching for a possible Duchenne muscular dystrophy clinical trial, they should try to find out their child\u2019s specific type of mutation.<\/p>\n

Duchenne is caused by various mutations in the dystrophin gene. Genes are comprised of segments called exons. These exons are supposed to fit together (much like puzzle pieces), but sometimes a piece may be missing or there may be an extra piece. A missing piece is called a deletion, while an extra piece is known as a duplication. In Duchenne muscular dystrophy, the most common mutation is a deletion.<\/p>\n

It\u2019s important to know your child\u2019s exact type of mutation because this information could open doors to possible clinical trials, as well as certain approved treatments.<\/p>\n

Many parents are interested to learn about Duchenne muscular dystrophy gene therapy clinical trials. Gene therapies aim to treat a disease, such as Duchenne muscular dystrophy, by correcting the underlying genetic problem. For example, gene therapy may aim to restore dystrophin by using a gene transfer. There are many clinical trials for\u00a0gene therapy for Duchenne muscular dystrophy<\/a>.<\/p>\n

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5) Who can participate in a Duchenne clinical trial?<\/strong><\/h3>\n

Duchenne muscular dystrophy clinical trials have specific criteria to determine who can participate. These criteria are known as clinical trial eligibility criteria.<\/p>\n

For example, the clinical trial eligibility criteria may state that the trial is seeking Duchenne patients with certain types of mutations, a specific age range, and ambulatory status among other inclusion and exclusion criteria.<\/p>\n

Clinical trial eligibility criteria help ensure that children with Duchenne who are participating in a trial are similar enough so that researchers can determine that the trial\u2019s outcomes are the result of the investigational new drug being evaluated. Clinical trial eligibility criteria are also designed with the safety of patients in mind.<\/p>\n

6) Will the clinical trial require any invasive procedures?<\/strong><\/h3>\n

Some Duchenne clinical trials may require diagnostics and possibly invasive procedures, such as surgical muscle biopsies. My son, Billy, underwent four invasive surgical muscle biopsies during his five years on the clinical trial. As a young boy, this was the most difficult part of the trial for him.<\/p>\n

7) What type of time commitment is involved, and how will this affect my work career or school career?<\/strong><\/h3>\n

This will vary by each trial. Billy enrolled in his clinical trial in August of 2011. We began traveling weekly from our home in Pittsburgh to Nationwide Children\u2019s Hospital in Columbus, Ohio. We traveled weekly out of state for the first year. While it was challenging for us to make the 3-hour trip to another state each week, most other families in the trial traveled from across the country.<\/p>\n

After the first year, all families were transferred to their local hospitals for their weekly infusions, while traveling out of state quarterly and eventually only twice a year for assessments at the clinical trial\u2019s main site.<\/p>\n

This rigorous clinical trial schedule undoubtedly affects both work and school careers. For example, I had to reduce my work hours and bring work projects to the hospitals, while Billy brought homework to the hospital.<\/p>\n

8) What costs may be involved in a clinical trial?<\/strong><\/h3>\n

It\u2019s important to consider all possible costs that may be involved in participating in clinical trials. Families usually do not have to pay for the majority of clinical trial costs. Drug manufacturers typically provide the drug used in a clinical trial free of charge.<\/p>\n

Most trials provide a daily allowance for hotel, parking, gas, food, etc. However, families should also consider other potential costs, such as childcare for other siblings and especially missed wages. We weren\u2019t paid for missing days of employment, but we advocated for this to change for future families. Families in the next phase of the clinical trial received a daily stipend for missed work.<\/p>\n

Parents should discuss any possible costs with the clinical trial staff and their insurance provider before enrolling in a clinical trial.<\/p>\n

9) Will there be side effects?<\/strong><\/h3>\n

This will vary from trial to trial and patient to patient. You should ask your child\u2019s pediatric neurologist and the principal investigator of your clinical trial about the potential side effects of your study drug.<\/p>\n

Side effects are unwanted and undesirable effects that may be related to a drug that a patient has taken. Side effects can range from minor issues, such as a headache or stuffy nose, to life-threatening or even fatal occurrences. Side effects are sometimes also called adverse reactions.<\/p>\n

10) What happens once the trial ends? Is there a way to access the drug after the trial ends?<\/strong><\/h3>\n

When a trial ends, sometimes a drug will be approved by regulatory authorities and will become available to the public. This is what happened with my son Billy\u2019s clinical trial. However, sometimes pharmaceutical companies may allow patients to use other pathways to access a drug after a clinical trial is completed. This is referred to as post-trial access. If you decide to enroll your child in a clinical trial, you may want to ask the principal investigator about whether there are any protocols for post-trial access.<\/p>\n

Final Thoughts<\/strong><\/h3>\n

Participating in a clinical trial is undoubtedly a large sacrifice, from the time commitment away from your child\u2019s school, separation from friends and family, additional expenses, and a parent\u2019s lost wages. However, being part of history and participating in a clinical trial that ultimately led to an approved treatment option for other children with Billy\u2019s type of Duchenne mutation made me feel like our sacrifice and commitment were worth it.<\/p>\n

We also have shared a camaraderie and a special bond with other families in the trial. This was our favorite part of making that weekly trip. Eleven years later, I still keep in touch with some of the other families. Being part of a trial was life-changing in many ways. We shared something historical together and our boys made an incredible contribution to medicine and science.<\/p>\n

myTomorrows offers a\u00a0<\/i>free service to help families find Duchenne Muscular Dystrophy clinical trials<\/i><\/a>.<\/i><\/p>\n

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The information in this blog is not intended as a substitute for a medical consultation. Always consult a doctor before receiving a diagnosis or treatment.<\/p>\n<\/div>\n

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The myTomorrows team
\nAnthony Fokkerweg 61-2
\n1059CP Amsterdam
\nThe Netherlands<\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Learn what questions parents should ask after their child gets a Duchenne Muscular Dystrophy diagnosis.<\/p>\n","protected":false},"author":13,"featured_media":4784,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[48],"tags":[108,127,156],"class_list":["post-3586","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-patients","tag-clinical-trials","tag-duchenne-muscular-dystrophy","tag-dmd"],"acf":[],"yoast_head":"\n10 Commonly Asked Questions about Duchenne Muscular Dystrophy Clinical Trials - myTomorrows<\/title>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"ar_AR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"10 Commonly Asked Questions about Duchenne Muscular Dystrophy Clinical Trials\" \/>\n<meta property=\"og:description\" content=\"Learn what questions parents should ask after their child gets a Duchenne Muscular Dystrophy diagnosis.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/patients\/10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials\/\" \/>\n<meta property=\"og:site_name\" content=\"myTomorrows\" \/>\n<meta property=\"article:published_time\" content=\"2022-09-05T12:42:55+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-02-27T13:26:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2022\/09\/shutterstock_1906046266.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1400\" \/>\n\t<meta property=\"og:image:height\" content=\"933\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Terri Ellsworth\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u0643\u064f\u062a\u0628 \u0628\u0648\u0627\u0633\u0637\u0629\" \/>\n\t<meta name=\"twitter:data1\" content=\"Terri Ellsworth\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u0648\u0642\u062a \u0627\u0644\u0642\u0631\u0627\u0621\u0629 \u0627\u0644\u0645\u064f\u0642\u062f\u0651\u0631\" \/>\n\t<meta name=\"twitter:data2\" content=\"9 \u062f\u0642\u0627\u0626\u0642\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/patients\/10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials\/\",\"url\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/patients\/10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials\/\",\"name\":\"10 Commonly Asked Questions about Duchenne Muscular Dystrophy Clinical Trials - myTomorrows\",\"isPartOf\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/patients\/10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/patients\/10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2022\/09\/shutterstock_1906046266.jpg\",\"datePublished\":\"2022-09-05T12:42:55+00:00\",\"dateModified\":\"2024-02-27T13:26:34+00:00\",\"author\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/#\/schema\/person\/bc4dc957f7fbb5c1f315c9898667e68c\"},\"breadcrumb\":{\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/patients\/10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials\/#breadcrumb\"},\"inLanguage\":\"ar\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/patients\/10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"ar\",\"@id\":\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/patients\/10-commonly-asked-questions-about-duchenne-muscular-dystrophy-clinical-trials\/#primaryimage\",\"url\":\"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2022\/09\/shutterstock_1906046266.jpg\",\"contentUrl\":\"https:\/\/main-portal.develop-mytomorrows.com\/wp-content\/uploads\/2022\/09\/shutterstock_1906046266.jpg\",\"width\":1400,\"height\":933,\"caption\":\"Overjoyed small boy patient with young mom visit male doctor greeting at consultation in hospital. 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