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Eplontersen for Amyloid Neuropathy
Study Summary
This trial will assess the safety of a new drug for a rare disease that causes nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing to follow the vitamin A supplement plan.I am a man following specific guidelines to prevent pregnancy during the trial.I am not pregnant or breastfeeding and follow specific birth control or sterility guidelines.You have completed a specific study as determined by the doctor and research sponsor, or have been diagnosed with a certain condition and completed another study as determined by the doctor and research sponsor.
- Group 1: Eplontersen
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many different medical clinics are managing this clinical trial today?
"There are 4 clinical trial sites operational at the moment, situated in Portland, Indianapolis and Boston as well as other cities. To cut down on travel, patients should enroll at the location that is closest to them."
How many individuals are enrolled in this research project?
"One hundred and forty patients that fit the bill are needed for this experiment. Those chosen can come from multiple hospitals, such as Oregon Health and Science University in Portland, Oregon or Indiana University Health University Hospital in Indianapolis, Indiana."
To your knowledge, does a similar study exist?
"3 trials for Eplontersen are ongoing in 88 cities and 25 countries. The first study was completed in 2020 by Ionis Pharmaceuticals, Inc. 168 individuals participated in the Phase 3 clinical trial which approved the drug. In the 2 years since then, 2 more studies have been conducted."
Does Eplontersen have any dangerous side effects that we should know about?
"Eplontersen is backed by Phase 3 trial data, indicating that multiple rounds of testing support both its efficacy and safety."
Are there any Eplontersen studies in the medical literature?
"Eplontersen was first studied in 2020 at Azienda Ospedaliera Universitaria Policlinico Gaetano Martino. There have been a total of 2 completed clinical trials since then. As of right now, 3 active trials are ongoing; a majority of these taking place in Portland, Oregon."
Are new participants being recruited for this research project?
"The study, which was originally posted on clinicaltrials.gov on 1/4/2022 is still recruiting participants. The most recent edit to the posting occurred on 11/3/2022."
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