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SOLAR
A clinical study for individuals ages 15-60 living with SMA
The SOLAR study is for individuals 15 to 60 years old with spinal muscular atrophy (SMA) and who have not yet taken any treatment or are currently taking risdiplam.
This study is evaluating a study drug called salanersen to understand its effects and safety in individuals ages 15-60 with SMA.
The SOLAR study is an open-label study, which means that all participants will receive the study drug. Specifically, all study participants will receive salanersen once a year for 5 years.
Participation is voluntary. Travel support is available.
About the SOLAR study
Evaluating an study drug for SMA
The SOLAR study is evaluating the effect of a study drug and how safe it is for the treatment of SMA in individuals 15 to 60 years old. It is important for clinical research to continue to explore different study drugs.
To join the SOLAR Study, you or your child must:
- Be between 15-60 years of age, inclusive
- Have a confirmed diagnosis of SMA
- Be able to sit without using support for at least 10 seconds
- Either:
- Have not received any prior medication specifically designed to treat the underlying cause of SMA, or
- Be currently receiving risdiplam, willing to stop taking it during the study, and have not been treated with any other medication specifically designed to treat the underlying cause of SMA
Other criteria also apply, which will be explained by the study team.
What causes SMA?
SMA is a rare, genetic disease that affects motor neurons. These are the nerves that control muscle movement. SMA weakens or destroys motor neurons, causing muscles to waste away. Over time, this can lead to problems with moving, breathing, and swallowing. SMA affects each person differently––some may notice motor function changes slowly, while others may see them more quickly.
In most people living with SMA, changes in a gene called survival motor neuron 1 (SMN1) – often referred to as gene mutations or variants – affect how this gene works. As a result, their bodies produce less SMN protein. There is another SMN2 gene that produces SMN protein, but it usually does not produce enough SMN protein on its own to make up for the changes in the SMN1 gene.
What is salanersen?
The study drug being evaluated in the SOLAR Study is called salanersen.
In people with SMA, changes in the SMN1 gene lower the overall amount of SMN protein in the body. Without enough of this protein, motor neurons and muscles lose their ability to work properly. A similar gene called SMN2 can help replace some of the lost SMN protein in the body. Salanersen works by helping the SMN2 gene to make more SMN protein.
In the SOLAR Study, all participants will receive salanersen once every year by intrathecal injection through a procedure called a lumbar puncture (LP). This means that the drug will be given through a needle into the fluid around the spinal cord and brain. Study participation will last a little over five years.
Salanersen is being tested in an ongoing phase 1 clinical study for participants with SMA who are ages six months to 12 years old. Researchers believe that salanersen could also be an effective option for individuals 15 to 60 years old with SMA.
How it works
You're not alone.
Here's how to get started.
1
Share your details
- Fill out the contact form so we can connect you with a Patient Navigator.
- Participation is voluntary, and you may stop at any time.
- Your personal information is kept private.
2
Quick eligibility check
- Answer a few questions to see if you or your child might be able to join the SOLAR Study.
- We only ask for the basic medical information needed to check if you or your child meet some of the eligibility criteria.
- If applicable, you or your child can schedule a free phone call with a Patient Navigator on a day and time that works best.
3
Meet your Patient Navigator
- Your Patient Navigator will explain the basics of the study, including what to expect and what is required.
- They will check some information, guide you or your child through the next steps, and answer any initial questions.
- If you or your child is interested and may meet some of the eligibility criteria, the Patient Navigator will connect you with a study site. The study team there will check if you meet all the required criteria for the study.
Frequently asked questions
How long is the study?
The total study duration is a little over 5 years long. Screening period lasts up to four weeks, where the study team will perform various tests and assessments to determine whether the study is a good match for you or your child. This involves one visit to the study site. If you or your child is found to be eligible, you or your child can choose to join the study.
Treatment and follow-up will last up to 5 years, where you or your child will receive the study drug given once a year. There will be 16 study site visits to monitor your well-being and to complete assessments, as well as 9 phone calls during this time. The frequency of study site visits will decrease over the five years.
The study team will walk you through the full timeline and answer any questions you may have. Your participation is completely voluntary, and you can withdraw at any time.
Will there be any reimbursement and/or travel support?
Yes. Travel reimbursement is available to you and your family to support your participation in the SOLAR Study. There is no cost for the study drug, study-related care, or monitoring.
What should we expect during the study?
If eligible, you or your child will receive the study drug, salanersen, once every 12 months by intrathecal injection (lumbar puncture). Throughout the SOLAR Study, there will be regular clinic visits to monitor effects and overall health. Blood, urine, and spinal fluid samples will also be collected to ensure safety and understand how the study drug works. Participants will also undergo physical and neurological exams as well as electrocardiograms (ECGs). There may be additional tests or assessments beyond those listed here; however, these will be reviewed and discussed further with the study team.
What kind of care will my child receive during the study?
You or your child can usually continue seeing their regular healthcare providers while participating in the study.
At the same time, the clinical study offers access to a dedicated study team who carefully monitors you or your child’s health and progress. This team focuses on the condition being studied and provides all study related medications and procedures at no cost. The study does not replace you or your child’s overall medical care but adds an extra layer of support.
What support or follow-up care is available after the study ends?
The study team will help you plan the next steps and share all study-related health information with you or your child’s regular doctor to help with continuity of care.
Find a study near you
SOLAR is a global study running at hospitals and clinics in approximately 19 countries around the world.
Your Patient Navigator will work with you to connect to the right site and answer any questions about travel or logistics.
See available study sites in the US on the map below:
Please read, your consent is required
If you or your child is 15-60 years old and has a diagnosis of Spinal Muscular Atrophy (SMA), you are invited to complete pre-screening questions to determine for participation in an SMA clinical study.
Biogen, the sponsor of this study, is responsible for the protection of your or your child’s personal information. Biogen has engaged myTomorrows (“myTomorrows”, “we” or “us”) to support study recruitment for the study by collecting pre-screening information for the study through this website.
With your consent, we will use this information to evaluate you or your child’s potential eligibility for the study.
The information that could identify you or your child will not be shared with Biogen. Only de-identified data will be shared with Biogen MA Inc.
You may withdraw your consent at any time and upon withdrawal of your consent we will promptly delete your personal data, except to the extent required to comply with our legal obligations. If you have a question, wish to withdraw consent, or exercise your other privacy rights, please contact myTomorrows at dataprotection@mytomorrows.com as Biogen MA Inc. will not receive any information that can directly identify you or your child. For more information about the Biogen Privacy Policy, please visit https://www.biogen.com/privacy-center.html or https://www.biogen.com/privacy-center/international-privacy.html.
After answering the pre-screener questions, you will have the opportunity to schedule a call with one of our Patient Navigators, who will collect additional information about you or your child’s health to assess the initial eligibility for this study. If potentially eligible, they will provide you with further information and answer questions about possible site locations, travel logistics and preferences, if applicable. If we find that you or your child may be eligible for this study, and you confirm your interest in participating, we will, with your consent, share the personal information collected with a clinical study site. The site will contact you to discuss next steps and answer any questions you may have. Your information may also be shared with other vendors of the Sponsor.
Even if you or your child does not qualify for this study, it is possible to schedule a call with one of our Patient Navigators to discuss other options that may be available.
We will retain your data for 2 years so we can get in touch with you if other options become available to you or your child during this time period.
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