ACTIVE – ALS Research Notification for Clinical Trials and Studies

The following are approved ALS studies and clinical trials that have used the National ALS Registry for patient recruitment purposes. Email notifications have already been sent out to persons living with ALS meeting the specific study criteria.

Active: currently recruiting for the specified clinical trial or study
To view list of closed (recruiting has ended) clinical trials and studies click here .

To receive automatic notifications about the latest clinical trials and studies, please join the Registry, click here.

This list will be updated as new research proposals are approved by ATSDR.

Please note, not all clinical trials are listed. To find the latest clinical trials, please visit ClinicalTrials.gov.

* Date most recent email was sent.

ALS Projects Supported via the Registry’s Research Notification Mechanism

1. Identifying Barriers and Facilitators to Exercise Among Individuals with ALS
The University of Alabama is conducting a study that aims to use Social Cognitive Theory to gain insight into the physical activity levels of people living with ALS, with the goal to develop deliverable educational content to enhance physical activity engagement. People living with ALS will be asked to fill out surveys and conduct interviews to capture their experiences and perspectives as it relates to exercise habits, levels of physical activity, exercise self-efficacy and social support they receive. The entire process can be completed in person, virtually, or over the phone, and will take approximately an hour and thirty minutes. Participation is completely voluntary, and choosing whether to participate will not affect your care at UAB or any other facility in any way
To learn more about this study, click here

2. The ALS Go-Digital Study
The Muscular Dystrophy Association (MDA), in partnership with Mitsubishi Tanabe Pharma America, is organizing a home study to see if the use of digital health technologies can be an effective and more convenient option to track ALS progression than frequent, potentially exhausting office visits.
To learn more about this study, click here [PDF – 213 KB]

3. Improving Shared Decision-making Surrounding Swallowing Impairments in Person’s Living with Amyotrophic Lateral Sclerosis (ALS)
The research study titled ” Improving Shared Decision-making Surrounding Swallowing Impairments in Person’s Living with ALS” is about the management of swallowing impairments for patients living with ALS. The purpose of the research is to determine patients, care givers, and healthcare practitioners’ beliefs, preferences, and concerns surrounding swallowing impairments in this population.
To learn more about this study, click here [PDF – 213 KB]

4. A Mindful Community for People with ALS and their Primary Caregivers
The study titled “A Mindful Community for People with ALS and their Primary Caregivers,” aims to explore and enhance the quality of life for individuals living with Amyotrophic Lateral Sclerosis (ALS) and their primary caregivers through an online mindfulness-based intervention. It is designed as an RCT, to investigate the impact of Langerian mindfulness on the psychological and physical wellbeing of people with ALS and their caregivers. This research is particularly important as it addresses both the individuals with the diagnosis and those who play a critical role in their care and support. We believe that our findings could lead to significant improvements in support strategies and overall quality of life for the ALS community.
To learn more about this study, click here [PDF – 213 KB]

5. Healey ALS Platform Trial
The HEALEY ALS Platform Trial is enrolling people living with Amyotrophic Lateral Sclerosis (ALS) to test the efficacy of multiple investigational products. The platform trial is designed to decrease the time it takes to test new potential therapies and increase access to research for people living with ALS. One of the innovative features of the Platform Trial is that enrollment will continue as more investigational products are added
To learn more about this study, email click here [PDF – 101 KB]

6. ALS Focus Survey Program
ALS Focus is patient- and caregiver-led survey program from The ALS Association that asks people with ALS, as well as current and past caregivers, about their needs and preferences throughout their disease journey. We are proud that every step of the survey development process is informed and reviewed by a committee of people with ALS and caregivers.

The goal is to learn as much as possible about individual experiences, needs, and challenges, so that the entire community can benefit. All information collected is de-identified and shared free of charge to researchers from all over the world and other organizations working on ALS. We are forming robust and accurate data showing the experiences and needs of people with ALS and their families. Open data helps us strengthen care for people with ALS and caregivers, accelerate therapy development, improve clinical trials, influence policy makers, and more.
For more information on ALS Focus and participating in surveys, please visit www.als.org/als-focus/

7. The ATLAS Study
The ATLAS Study is part of a larger clinical research effort to evaluate the safety, dosing, and efficacy of an investigational
drug (tofersen) delivered via intrathecal administration in people who have a confirmed SOD1 gene variant. The ATLAS study
will evaluate whether starting tofersen early (before clinical signs or symptoms that indicate the onset of ALS) will delay the appearance of signs or symptoms of ALS and/or reduce the loss of function over time as compared with starting tofersen once signs or symptoms appear.
To learn more about this study click here

8. Radicava®/(Edaravone) Findings in Biomarkers From ALS
Radicava has been shown to slow the loss of physical function in ALS and was approved by the FDA in May of 2017 as a treatment for ALS. In this research study we want to learn what changes happen in patients with Amyotrophic Lateral Sclerosis (ALS) that can be seen in the blood and urine when taking Radicava. These measurable indicators of change are called biomarkers. This study hopes to learn more about the biology of ALS, disease progression, and the treatment effect of Radicava by studying biomarkers. The study plans to enroll up to 300 patients who will take Radicava over a 24 week period. Participants are to complete 6 cycles of Radicava infusion and provide blood and urine for analysis. You may be eligible for this study if you have been diagnosed with ALS, are 18 years or older and after discussion with your physician, the decision was made to prescribe Radicava. Study participants will obtain drug through their own current medical/pharmacy coverage plan (i.e. Medicare, HMO, PPO, etc.).
To learn more about this study, email click here [PDF – 142 KB]

9. Primary Lateral Sclerosis Natural History Study
The purpose of this study is to improve the current research status of Primary Lateral Sclerosis (PLS) by studying the natural history of the disease to determine how it progresses without any drug treatment. We’re hoping that information gained from this project will prepare the research community for future clinical trials in PLS.
To learn more about this study, click here [PDF – 4 MB]

10. Feasibility of the BrainGate2 Neural Interface System in Persons with Tetraplegia
The goal of the BrainGate2 Clinical Trial is to see if a new medical device called the BrainGate2 Neural Interface System (also called “BrainGate”) is safe and effective at giving people with paralysis the ability to control a computer cursor and other assistive devices with their thoughts.
To learn more about this study, email clinicaltrials@braingate.org

11. Evaluation of IONIS in FUS-ALS Patients
The primary purpose of this study is to evaluate the clinical efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS). IONIS hopes to obtain more information on the efficacy, safety, pharmacokinetics and pharmacodynamics of the study ION363 in patients suffering from the rare FUS genetic mutation associated with ALS.
To learn more about this study click here