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Study Summary
This trial is looking at the safety and effectiveness of a drug for people with ALS and a specific gene mutation.
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.Side effects data
From 2021 Phase 3 trial • 176 Patients • NCT02623699Trial Design
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Who is running the clinical trial?
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- I can follow the study's schedule and procedures.I started taking edaravone more than 60 days ago and won't take it on study dosing days.I haven't taken any experimental drugs or used new medical devices recently.I have a high risk of bleeding due to conditions affecting my blood or the area where a spinal tap would be performed.I have not had treatments like RNA interference, stem cell, or gene therapy.I am not pregnant or breastfeeding.I have SOD1-ALS and finished a part of Study 233AS101 without withdrawing.I have been on a stable dose of riluzole for at least 30 days.I am currently using, or might need, specific medications as determined by my doctor.I have been on a stable dose of riluzole for at least 30 days.
- Group 1: BIIB067
- 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
Are there any patients who have not yet been enrolled in this research?
"Unfortunately, this specific clinical trial is no longer looking for patients. However, there are 3 other trials with similar treatments that are still recruiting candidates."
Have these treatments been tested before in a clinical setting?
"BIIB067 has been trialed in 32 cities and 16 countries. The first clinical trial was completed in 2017 by 138 participants. These trials are sponsored by Biogen and, as of now, 2 studies are still active."
Are there any know risks associated with taking BIIB067?
"There is both efficacy and safety data available for BIIB067 because it has progressed to Phase 3 trials. As such, our team has given it a score of 3."
In how many different medical institutions is this research being conducted currently?
"Right now, this trial is being conducted at 20 different sites. While the majority of these locations are in close proximity to major cities like Orlando, Jacksonville and Boston, it is still important that patients select the location closest to them to minimize travel time and costs."
How many individuals are currently taking part in this clinical research?
"Unfortunately, this study is no longer recruiting patients. The trial was first posted on March 8th, 2017 and ended recruitment on September 2nd, 2021. However, there may be other studies you are eligible for; as of right now, there is one active clinical trial for patients with ALS caused by a superoxide dismutase 1 (SOD1) mutation and two trials for BIIB067 that are still enrolling participants."
Are there any other instances in which BIIB067 has been studied?
"There are 80 clinical trial sites for BIIB067 across the globe, with 2 of them currently in Phase 3."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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