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Elamipretide for Friedreich Ataxia Vision Loss (ELViS-FA Trial)
ELViS-FA Trial Summary
This trial is testing a drug to see if it is safe and effective in treating vision loss in people with Friedreich Ataxia.
ELViS-FA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowELViS-FA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 41 Patients • NCT02245620ELViS-FA Trial Design
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- You have very low white blood cell count, low hemoglobin, or very high or very low platelet count based on a blood test.My medications and supplements have been the same for the last 30 days.I am currently taking Metformin.I do not have severe kidney or liver disease.My vision is worse than 20/40 due to FRDA and cannot be corrected.My heart's pumping ability is reduced, and I have vision issues but can see fairly well.I have an active HIV or Hepatitis B/C infection.My condition started before I turned 18.I do not have any active eye nerve issues or heart disease caused by vitamin deficiencies.If you are a woman, you are not pregnant, breastfeeding, or planning to get pregnant during the study or within 30 days after the study ends. If you could become pregnant, you need to have a negative pregnancy test before starting the study.My medications and supplements have been the same for the last 30 days.I am currently taking medication that weakens my immune system.You have a history of using drugs or alcohol in a harmful way.I am older than 16 years.Your heart's pumping ability is less than 35% based on the latest heart ultrasound.This criterion does not apply to me.My Friedreich's ataxia is confirmed through genetic testing.I have an irregular heartbeat that is not under control.My condition started before I turned 18.I am older than 16 years.
- Group 1: Low Dose (20-30mg)
- Group 2: High Dose (40-60 mg)
- 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
What is the maximum capacity of participants in this clinical trial?
"This medical research is no longer recruiting participants. Initially posted on March 3rd of 2022, the trial was last updated on July 27th of 2022. Nevertheless, there are currently 46 studies for Friedreich Ataxia and 2 trials concerning Elamipectide that are actively enlisting individuals."
Are recruitment efforts ongoing for this clinical experiment?
"The clinical trial posted on March 3rd 2022 is not currently taking applicants. It was last updated in July 27th 2022. Despite this, there are 48 other trials that require patient enrolment at the present time."
Is this research groundbreaking in its methodology?
"Presently, two ongoing trials of the drug Elamipretide are taking place in 14 cities and 10 countries. The original study, sponsored by Stealth BioTherapeutics Inc., commenced back in 2022 with 18 participants and successfully completed Phase 1 & 2 of its clinical trial process. Since then, 17 additional studies have been concluded."
Are there additional investigations centered around Elamipretide?
"At this moment, two clinical trials are actively researching the effectiveness of elamipretide. Of these, one is in its final stage (phase 3). Most of the studies take place at a single location in Portland; however there are 32 other research sites taking part as well."
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