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Taldefgrobep Alfa for Spinal Muscular Atrophy (RESILIENT Trial)
RESILIENT Trial Summary
This trial will study if adding taldefgrobep alfa to current treatments for spinal muscular atrophy (SMA) is effective and safe.
RESILIENT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESILIENT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RESILIENT Trial Design
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Who is running the clinical trial?
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- I need a ventilator to breathe during the day.I can walk with or without assistance.I have been genetically diagnosed with Spinal Muscular Atrophy.I am currently on a stable dose of SMA treatment and plan to stay on it.I weigh at least 15kg.I had spinal fusion surgery less than 6 months ago, but adjustments to MAGEC rods are okay.You have a device in your body to drain fluid from your brain or a catheter in your central nervous system.I have never taken anti-myostatin therapies.
- Group 1: taldefgrobep alfa
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Will this experimental treatment be available to those who are elderly?
"Children and adolescents aged 4-21 may be eligible for this clinical trial. There are currently 63 similar studies for those under 18 and 173 for senior citizens."
What is the mortality rate of tadefgrobep alfa?
"While Phase 3 trials are not as well established as Phase 4 trials, there is still some supporting data for efficacy and safety. Therefore, our team has given tadefgrobep alfa a safety score of 3."
What are the entrance requirements for this research project?
"This trial is open to 225 people with Oppenheim Disease who are between the ages of 4 and 21. Applicants must meet the following criteria: Ambulant or Non-Ambulant, Spinal muscular atrophy confirmed by genetic diagnosis of 5q-autosomal recessive SMA as well as SMN2 copy number, Treated with an SMA disease-modifying therapy and anticipated to remain on that same treatment regimen and dose throughout the trial including nusinersen, risdiplam, and/or a history of onasemnogene abeparvovec, Key."
Could you please give me the number of medical facilities where this research is being conducted?
"There are a total of 34 locations hosting this clinical trial, with children's hospitals in Phoenix, Gainesville, and Chicago participating."
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