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Antisense Oligonucleotide
Tofersen for ALS (ATLAS Trial)
Phase 3
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who are clinically presymptomatic for ALS (i.e., must not have clinically manifest ALS).
Participants who are clinically presymptomatic for ALS (i.e., must not have clinically manifest ALS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up parts b and c: up to 5.6 years and part d: up to 2 years
Awards & highlights
ATLAS Trial Summary
This trial is testing a new drug for people with a specific genetic mutation that causes ALS. The goal is to see if the drug can help delay or prevent the onset of symptoms.
Who is the study for?
This trial is for adults who carry a specific gene mutation (SOD1) linked to ALS but don't yet show symptoms. They must have low neurofilament levels and not be on certain ALS treatments or other clinical trials. People with severe mental health issues, active infections like HIV or hepatitis, or those at risk of bleeding complications can't participate.Check my eligibility
What is being tested?
The study tests Tofersen's effectiveness in delaying the onset of ALS symptoms in people with an SOD1 mutation. Participants will either receive Tofersen or a placebo without knowing which one they're getting to compare outcomes fairly.See study design
What are the potential side effects?
While the side effects aren't detailed here, similar studies suggest potential reactions could include injection site reactions, liver enzyme changes, and flu-like symptoms. The trial aims to monitor safety closely.
ATLAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not show any symptoms of ALS.
Select...
I do not show any symptoms of ALS.
Select...
My ALS is due to a specific SOD1 mutation confirmed by experts.
Select...
My ALS is due to a specific SOD1 mutation confirmed by experts.
ATLAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ parts b and c: up to 5.6 years and part d: up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~parts b and c: up to 5.6 years and part d: up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amyotrophic Lateral Sclerosis
Secondary outcome measures
Parts B and C: Change from Baseline in Percent Predicted Slow Vital Capacity (SVC)
Parts B and C: Change in ALS Functional Rating Scale (ALSFRS-R) Total Score
Parts B and C: Percentage of Participants with Outcome as Death or Permanent Ventilation Based on Time to Death or Permanent Ventilation Analysis
+5 moreATLAS Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Part D: Open-Label TreatmentExperimental Treatment1 Intervention
Participants from Part A who develop clinically manifest ALS prior to randomization in Part B may be eligible to participate in Part D. During Part D, participants will receive tofersen100 mg via IT injection on Days 1, 15, 29, and every 28 days thereafter for up to 2 years.
Group II: Part C: Open-Label ExtensionExperimental Treatment2 Interventions
Participants from Part B who develop clinically manifest ALS may be eligible to participate in Part C. During Part C, participants who received placebo in Part B will receive tofersen 100 mg via IT injection on Days 1, 15, 29, and every 28 days thereafter up to the final maintenance dost visit. Participants who received tofersen during Part B will receive tofersen 100 mg on Days 1, 29, and every 28 days thereafter up to the final maintenance dost visit, with a dose of placebo on Day 15 to maintain the study blind. The combined duration of Part B and Part C is up to approximately 5.6 years.
Group III: Part B: Randomized, Double-Blind, Placebo-ControlledExperimental Treatment2 Interventions
Participants from Part A who meet the protocol-defined NfL threshold and remain presymptomatic may be eligible to participate in Part B. During Part B, participants will receive tofersen 100 milligram (mg) or placebo via intrathecal (IT) injection on Days 1, 15, 29, and every 28 days thereafter for up to approximately 5.6 years.
Group IV: Part A: Natural History Run-inActive Control1 Intervention
Participants enrolled in Part A will undergo blood draws approximately once every 28 days to assess neurofilament light chain (NfL) levels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Tofersen
2018
Completed Phase 3
~190
Find a Location
Who is running the clinical trial?
BiogenLead Sponsor
639 Previous Clinical Trials
467,246 Total Patients Enrolled
11 Trials studying Amyotrophic Lateral Sclerosis
2,698 Patients Enrolled for Amyotrophic Lateral Sclerosis
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,334 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
798 Patients Enrolled for Amyotrophic Lateral Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stopped my ALS medications for enough time before screening.I do not show any symptoms of ALS.I haven't taken any experimental drugs or treatments recently.I might need medication that affects blood clotting and cannot be stopped for a spinal tap.I either have hepatitis B or am immune to it due to past infection or vaccination.You have a neuromuscular or neurological disorder that is getting worse and could affect the study.I do not show any symptoms of ALS.You have an active hepatitis C infection, which means that the virus can be found in your blood. If you have a positive hepatitis C antibody but the virus cannot be detected in your blood, you can participate in the study.My ALS is due to a specific SOD1 mutation confirmed by experts.I am using treatments not officially approved for ALS.My ALS is due to a specific SOD1 mutation confirmed by experts.You have severe problems with memory or thinking, or unstable mental health issues like severe depression or thoughts of hurting yourself.I am not currently in, nor planning to join, any other treatment studies.I am at high risk for bleeding during or after surgery.Your blood test shows a lower level of plasma NfL than what is required for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Part D: Open-Label Treatment
- Group 2: Part A: Natural History Run-in
- Group 3: Part B: Randomized, Double-Blind, Placebo-Controlled
- Group 4: Part C: Open-Label Extension
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the research history of BIIB067 (Tofersen)?
"BIIB067 (Tofersen) was first researched in 2017 at the Calgary, Alberta location. To date, there have been a total of 18,241 completed studies. At the moment, there are 2 active studies."
Answered by AI
Are there a number of these trials taking place in different states?
"There are 25 sites currently enrolling for this clinical trial, these locations include but are not limited to: Research Site in Calgary, Columbia University Medical Center in La Jolla, and Austin Neuromuscular Center in Scottsdale."
Answered by AI
Are there any current openings for participants in this clinical trial?
"That is correct. The clinicaltrials.gov website has information indicating that this study is still looking for patients. This research was first made public on May 17th, 2021 and was last edited on October 27th, 2022. The study will have a total of 150 patients between 25 different locations."
Answered by AI
What is the total number of people taking part in this research project?
"One hundred and fifty people who meet the inclusion criteria are needed to complete this clinical trial. There are several locations where patients can take part in this trial, such as the research site in Calgary, Alberta and Columbia University Medical Center in La Jolla, California."
Answered by AI
Are there any harmful side effects associated with BIIB067 (Tofersen)?
"Tofersen (BIIB067) is estimated to be a safe drug, as it has received a 3 on Power's safety scale. This is due to the fact that Tofersen is a Phase 3 trial drug, meaning that there is some data supporting its efficacy and multiple rounds of data supporting its safety."
Answered by AI
Is this a groundbreaking clinical trial?
"Clinical trials for BIIB067 (Tofersen) began in 2017 and the drug received approval after the first Phase 3 trial. There are currently two live trials underway, spanning 32 cities and 16 countries."
Answered by AI
Who else is applying?
What state do they live in?
California
Massachusetts
How old are they?
18 - 65
What site did they apply to?
California Pacific Medical Center
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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