ALS Clinical Trials and Studies
The Lois Insolia ALS Clinic at the Les Turner ALS Center at Northwestern Medicine is actively involved in multi-center drug trials. Our clinical research in ALS encompasses a broad range of work, including biomarker studies, open label therapeutic studies, natural history studies and clinical trials.
Choosing to participate in a clinical trial or study is an important personal decision. We encourage you to talk with your doctor and family members or friends about deciding to join a study. You should talk with your physician about the inclusion/exclusion criteria for participation in any trial.
Our resources can help you learn about ALS clinical research and decide whether participation is right for you.
To learn more about clinical trials and studies at Lois Insolia ALS Clinic at the Les Turner ALS Center at Northwestern Medicine, please contact Emma Schmidt, Clinical Research Coordinator, at emma.schmidt@northwestern.edu or (312) 503-4362.
Updated July 30, 2024
Enrolling ALS Clinical Trials
Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)
About Phase 2 Trial
A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with ALS
Contact: Emma Schmidt, Clinical Research Coordinator
emma.schmidt@northwestern.edu or (312) 503-4362
BIIB067 SOD1-ALS Presysmptomatic (ATLAS)
About Phase 3 Trial
A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation (ATLAS).
The primary objective of this study is to evaluate the efficacy of BIIB067 when initiated in presymptomatic adult carriers of a superoxide dismutase 1 (SOD1) mutation with elevated neurofilament (NF). The secondary objectives of this study are to evaluate the safety and tolerability of BIIB067 and to evaluate the effect of BIIB067 on pharmacodynamics (PD)/treatment response biomarkers when initiated prior to versus at the time of emergence of clinically manifest amyotrophic lateral sclerosis (ALS).
Contact: Emma Schmidt, Clinical Research Coordinator
emma.schmidt@northwestern.edu or (312) 503-4362
Enrolling Studies: Clinical Research to Understand ALS and PLS
ALS/MND Natural History Consortium
The purpose of this research study is to collect clinical information from people living with ALS and other motor neuron disorders through the natural history of their disease. Data is obtained from the participants during their standard of care visits and by reviewing their medical records.
The objective of compiling clinical, phenotypic data over the course of the participants’ disease history is to identify clinical similarities, improve our understanding of these diseases longitudinally, and identify avenues for novel treatment.
The National Amyotrophic Lateral Sclerosis Registry
The purpose of this registry is to better describe the incidence and prevalence of Amyotrophic Lateral Sclerosis (ALS) in the United States; examine appropriate factors, such as environmental and occupational, that may be associated with the disease; better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and better examine the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.
> Enroll in the National ALS Registry
Contact: Cara F. Gallagher M.A., LCPC
cgallagher@lesturnerals.org or (847) 745-6053
Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone
This study is being conducted to help the investigators better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. The investigators are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of ALS
There is no study medication being offered in this trial. Edaravone is prescribed as part of regular care. In this trial we are collecting blood, urine, and spinal fluid samples in ALS patients who are taking Edaravone and ALS patients who are not taking Edaravone to measure certain markers that could indicate why the drug may be working in a specific type of ALS.
Use of Glenohumeral Injections for Management of Shoulder Pain in Individuals with ALS
The purpose of this study is to develop a practice for measuring the efficacy of ultrasound-guided shoulder joint injections in patients with ALS who have exhibited shoulder pain and/or adhesive capsulitis. Patients will receive corticosteroid injections as part of their normal or standard care for shoulder pain in ALS (not provided by the study). They will then be asked to complete questionnaires at Baseline and over the phone over approximately 3 months.
Contact: Emma Schmidt, Clinical Research Coordinator
emma.schmidt@northwestern.edu or (312) 503-4362
Expanded Access Program
Resources
ALS & Participation in Clinical Research Guide
Participating in a clinical research study is an important and personal decision. You can follow these steps to learn about clinical research studies, explore your options, and decide if participating in a study is right for you.
Clinical Research Decision Tool - Coming Soon
ELA y participación en investigaciones clínicas
Participar en un estudio de investigación clínica es una decisión importante y personal. Puede seguir estos pasos para informarse sobre los estudios de investigación clínica, explorar sus opciones y decidir si participar en un estudio es adecuado para usted.
Clinical Research Team
Senda Ajroud-Driss, MD
Emma Schmidt
Cara Gallagher, MA, LCPC
Testing New ALS Treatments with Urgency
The Les Turner ALS Foundation is committed to accelerating enrollment in ALS clinical research and increasing access to clinical trials, expanded access protocols, and non-therapeutic research studies. Through partnerships with organizations like the Sean M. Healey & AMG Center at Massachusetts General Hospital, we participate in innovative programs like the HEALEY ALS Platform Trial and the Acceleration Centers of Enrollment (ACE) initiative.
"Our goal is to shorten the time that it takes to do traditional clinical trials and broaden patient access to trials, which will help us better understand this disease,” said Senda Ajroud-Driss, MD, Director of the Lois Insolia ALS Clinic.
Enrollment Completed
Additional Resources
The Northeast Amyotrophic Lateral Sclerosis Consortium® (NEALS) is the world’s largest consortium of clinical research sites dedicated to rapidly translating scientific advances into clinical research and new treatments for people with ALS. Through the ALS Clinical Research Learning Institute® (CRLI) Research Ambassador Program for people impacted by ALS, NEALS actively supports the integration of lived experience into the global drug development process by creating collaboration opportunities within the patient community, academia and industry that ensure a patient-centric approach to treatment discovery.
The ALS Trial Navigator (ALS.net/ALS-Trial-Navigator) is a comprehensive resource that helps people living with ALS, find and participate in clinical trials for ALS. After answering a few questions, you can learn about research opportunities, set personal priorities, and find trials that meet your criteria. The Navigator also has an interactive map to help you find trials in your area.
ALSUntangled provides scientific reviews of alternative or off-label treatments to help people living with ALS make more informed decisions. Explore treatment reviews, questions and answers, podcast episodes, and more at ALSUntangled.com.
