Finding a clinical trial and/or observational study that is a good fit for you may take some patience and persistence. Guidance from your clinical team, support from loved ones, and online search tools can make the process easier.
Getting Started
|
No one knows your clinical situation better than your own ALS clinic team. They may have insights into particular trials or studies that are not available online. However, not all neurologists talk about research opportunities with their patients, so you may need to ask about research and express your interest in participating.
|
|
Ask whether your ALS clinic conducts trials or studies on site—or if they can recommend trials or studies in your area that are currently enrolling. You can also reach out to your local ALS organization or another ALS clinic in your area.
In addition to speaking with local ALS professionals, it’s important to search online to learn about all available trials and studies. Today, there are powerful online search tools with filters that can narrow down the options that meet your criteria.
Before you begin your search, it may be helpful to set up a digital or paper-based organizational system where you can take notes and track details. You can also ask a family member or friend to assist with the search.
In addition to speaking with local ALS professionals, it’s important to search online to learn about all available trials and studies. Today, there are powerful online search tools with filters that can narrow down the options that meet your criteria.
Before you begin your search, it may be helpful to set up a digital or paper-based organizational system where you can take notes and track details. You can also ask a family member or friend to assist with the search.
Clinical Trials vs. Observational Studies
In a clinical trial, you take an experimental drug or treatment to find out if it has any effect on your disease progression. In an observational study, you do not take an experimental drug or treatment. Instead, you provide information and sometimes samples that help researchers build a better understanding of ALS.
You cannot usually participate in two clinical trials at once, but you can most likely participate in a clinical trial and an observational study at the same time. Always ask the research teams to make sure.
You cannot usually participate in two clinical trials at once, but you can most likely participate in a clinical trial and an observational study at the same time. Always ask the research teams to make sure.
ALS Trial Navigator
|
The ALS Trial Navigator is a user-friendly online search tool for people looking for an ALS clinical trial or observational study. It was developed by ALS TDI and is managed in partnership with NEALS.
|
|
The ALS Trial Navigator’s database gathers information from ClinicalTrials.gov, the World Health Organization, and individual research study teams. This powerful tool offers multiple ways to search and includes other helpful resources, such as a comprehensive FAQ page with information about participating in clinical research.
There are three main ways to use the Trial Navigator to search for trials and studies:
The Healthcare Provider Quick Start (HCPQS) allows healthcare providers to quickly search for ALS clinical trials based on location and eligibility criteria, making it easier to identify potential opportunities to share with patients who are interested in research.
There are three main ways to use the Trial Navigator to search for trials and studies:
- The Guided Trial Finder asks you a series of questions on topics such as your symptoms, current medications, geographical range, and research participation preferences. Once completed, you receive a list of trials and studies that match your criteria. If you want to broaden your search criteria, you can go back to the questionnaire and adjust your answers.
- The Trial Browser provides a comprehensive list of all opportunities, which are divided into three tabs: Interventional (clinical trials), Observational (observational studies), and Symptom Management. Within each category, you can apply filters such as location, recruitment status, genetic studies, trial phase, and open-label extension option.
- The ALS Trial Map lets you explore the locations of ALS trial sites all over the world, so you can search for trials based on your preferred location.
The Healthcare Provider Quick Start (HCPQS) allows healthcare providers to quickly search for ALS clinical trials based on location and eligibility criteria, making it easier to identify potential opportunities to share with patients who are interested in research.
Tips for Using the ALS Trial Navigator
You can use either Trial Navigator tool without creating an account. However, creating an account allows you to save your search results and return to your personalized dashboard.
Once you have your list of filtered results, you will see general information such as study location, duration, and recruitment status. Click on a specific trial or study to view its description, contact information, and eligibility criteria. When exploring the Locations section near the bottom of the page, be sure to scroll down to see all locations.
Even though the ALS Trial Navigator is a user-friendly search tool, the descriptions and information provided by each trial or study may feel technical and hard to follow. If you find one of interest, reach out to the research study team. They should be able to explain everything clearly and answer your questions.
If you have genetic ALS, there is a Genetic Target filter on the Trial Browser. You can select “Show All” or select one gene at a time. If you are a gene carrier without symptoms, you can select “Asymptomatic Carriers Only” or do a separate search for “Asymptomatic Carriers Allowed”.
If you are a person without ALS who would like to serve in a control group, open the “Observational” tab in the Trial Browser and apply the “Healthy Volunteers Allowed” filter.
Once you have your list of filtered results, you will see general information such as study location, duration, and recruitment status. Click on a specific trial or study to view its description, contact information, and eligibility criteria. When exploring the Locations section near the bottom of the page, be sure to scroll down to see all locations.
Even though the ALS Trial Navigator is a user-friendly search tool, the descriptions and information provided by each trial or study may feel technical and hard to follow. If you find one of interest, reach out to the research study team. They should be able to explain everything clearly and answer your questions.
If you have genetic ALS, there is a Genetic Target filter on the Trial Browser. You can select “Show All” or select one gene at a time. If you are a gene carrier without symptoms, you can select “Asymptomatic Carriers Only” or do a separate search for “Asymptomatic Carriers Allowed”.
If you are a person without ALS who would like to serve in a control group, open the “Observational” tab in the Trial Browser and apply the “Healthy Volunteers Allowed” filter.
ClinicalTrials.gov
|
ClinicalTrials.gov is a comprehensive database for clinical trials and observational studies around the world. It is run by the National Institutes of Health (NIH). Although it includes all diseases, you can filter for ALS.
This search tool has so much information that it can feel overwhelming. But once you learn how to use it and apply the right filters, it can be very helpful. We have provided some tips in the box below. You will likely find it easier to navigate on a larger computer or tablet screen than on a phone. |
|
You can start by using the main filters on the homepage to find potential trials or studies:
- Condition/disease: Type in “Amyotrophic Lateral Sclerosis”.
- Other terms: You can leave this blank, or, if you know something specific you are looking for, you can try typing it in here.
- Intervention/treatment: You can leave this blank, or, if you know the name of the trial or study drug you are looking for, you can try typing it in here.
- Location: Type in your city or state to see what is near you. You can also type in your country if you are willing to travel farther.
- Study Status: Click “Recruiting and not yet recruiting studies."
Tips for Using ClinicalTrials.gov
There are many other filters you can apply, including Study Type, which lets you search for Interventional (clinical trials) and/or Observational (observational studies).
Once you’ve applied your filters and clicked Search, you will see a list of the trials or studies that match your criteria. Click on the study title for details. You can scroll down to see all the information or click on the side tabs to jump to relevant sections such as:
When you find a clinical trial or observational study you may be eligible for, you can save or download the study information. For additional tips and guidance on ClinicalTrials.gov, visit their How to Search for Clinical Studies page.
Once you’ve applied your filters and clicked Search, you will see a list of the trials or studies that match your criteria. Click on the study title for details. You can scroll down to see all the information or click on the side tabs to jump to relevant sections such as:
- Study Overview: This is the main study summary, which may feel academic and technical.
- Participation Criteria: Check the inclusion and exclusion criteria to find out if you might be eligible. If you are still unsure, you can contact the research team conducting the trial or study or ask your ALS clinic team.
- Contacts and Locations: This is where you should be able to find the name and phone number and/or email of the research team’s primary contact person. Generally, study sponsors only list sites that are ready to enroll participants. To find out if there are sites near you that are not listed on clinicaltrials.gov, reach out to the study sponsor. Their contact information is listed under “Study Contact”.
When you find a clinical trial or observational study you may be eligible for, you can save or download the study information. For additional tips and guidance on ClinicalTrials.gov, visit their How to Search for Clinical Studies page.
ClinicalTrials.gov does not have a dedicated genetic filter, so if you have genetic ALS, you can type specific terms like genetic ALS or familial ALS into the “Other Terms” field to narrow your search. To search by a specific gene, enter the full name of the gene (i.e. C9orf72 instead of C9).
If you are a gene carrier without symptoms, you can type specific terms like presymptomatic (or pre-symptomatic) gene carrier, asymptomatic gene carrier, at-risk for ALS, and genetic into the “Other Terms” field to narrow your search. To search by a specific gene, enter the full name of the gene (i.e. C9orf72 instead of C9).
If you are a person without ALS who would like to serve in a control group, click on More Filters, check the Accepts Healthy Volunteers box, and click Observational under Study Type.
If you are a gene carrier without symptoms, you can type specific terms like presymptomatic (or pre-symptomatic) gene carrier, asymptomatic gene carrier, at-risk for ALS, and genetic into the “Other Terms” field to narrow your search. To search by a specific gene, enter the full name of the gene (i.e. C9orf72 instead of C9).
If you are a person without ALS who would like to serve in a control group, click on More Filters, check the Accepts Healthy Volunteers box, and click Observational under Study Type.
Additional Search Tools
Here are some additional online search tools that you may find helpful:
- The ALS Signal Dashboard by I AM ALS was created by ALS patients, caregivers, and advocates. It focuses exclusively on disease-modifying interventional clinical trials for ALS (not observational studies or symptom management trials). You can search by drug, genetic target, and other criteria.
- The ALS Network’s clinical trial finder uses artificial intelligence (AI) to provide a user-friendly interface, multiple ways to search and filter, and prebuilt forms for emailing research study teams.
- EverythingALS has developed an online tool called SAVA AI that uses AI to match people with ALS clinical trials and observational studies.
- The World Health Organization’s International Clinical Trials Registry Platform (ICTRP) is an online tool that allows you to search for trials around the world, including trials that target rare genetic variants.
Verify What You Find
All of these online search tools can be very helpful for finding clinical trials and observational studies that might work for you. However, these tools do not always have the most current information. This is because sometimes research teams do not update their listings on ClinicalTrials.gov, and most search tools pull much of their information from this database. Once you find a trial or study of interest, it is important to follow up directly with research teams to verify enrollment status and other details.
Enrolling in Observational Studies
Observational studies typically have broader eligibility criteria than clinical trials and enroll more participants. Most studies are open to everyone who has an ALS diagnosis. Some studies require in-person visits, some can be done completely from home, and others are hybrid. Generally speaking, enrolling in an observational study is easier and faster than enrolling in a clinical trial.
“Participating in a clinical trial or an observational study does more than advance scientific knowledge. It allows a person living with ALS to be an active partner in the fight against this disease.”
- Andrea Pauls Backman, Founder, ALS Strategy Consulting
- Andrea Pauls Backman, Founder, ALS Strategy Consulting
Enrolling in Clinical Trials
Once you’ve found a specific trial that may be a good fit, share the information with your ALS clinic or medical team and ask for their input. Then, reach out to the research team by phone, email, or online contact form. If you do not hear back, try again and make sure you have the correct contact information.
Each ALS clinical trial site has a dedicated research team that should have the most accurate and up-to-date information for their trial. The principal investigator is the doctor or scientist who is leading the trial at that location. Your main point of contact, typically the research coordinator, may be a nurse or administrative assistant.
The first step may be a call, email exchange, or in-person visit. During the screening process, the research team will ask you questions to confirm your eligibility. You may be asked to provide a medical history and visit the site for a physical exam.
Each ALS clinical trial site has a dedicated research team that should have the most accurate and up-to-date information for their trial. The principal investigator is the doctor or scientist who is leading the trial at that location. Your main point of contact, typically the research coordinator, may be a nurse or administrative assistant.
The first step may be a call, email exchange, or in-person visit. During the screening process, the research team will ask you questions to confirm your eligibility. You may be asked to provide a medical history and visit the site for a physical exam.
ALS Research for Military Veterans
If you are a U.S. military Veteran living with ALS, all the information on this page applies to you. Visit our Veterans Research page to learn about specific considerations and opportunities for Veterans.
What questions should I ask about clinical trials?
Remember that while the research team is evaluating your participation, you want to make sure this particular trial is a good fit for you. Here are some ideas for questions you could ask:
Eligibility
About the Experimental Drug or Treatment
About the Trial
Commitment
Before your call or visit, add any other questions you may want to ask. You can also ask the research team ahead of time if there are any questions you should ask.
Eligibility
- What are the inclusion and exclusion criteria? Do I qualify?
- Can I continue taking my current medications and/or supplements?
- Can I take or start taking an approved drug for ALS while participating in this trial?
- What paperwork will I need to submit?
- Is an in-person visit required for a physical exam?
About the Experimental Drug or Treatment
- What type of drug or treatment will I be taking?
- What are the potential benefits?
- What are the potential risks?
- How often will I need to take the drug or treatment?
- How will the drug be delivered (e.g. pill, injection, IV, intrathecal (spinal) injection)?
About the Trial
- What phase is the trial in?
- What percentage of participants will receive a placebo?
- When the trial ends, will I find out if I was taking the drug or placebo?
- When the trial ends, can I continue taking or start taking the drug?
- When will the results of the trial be shared with me?
- What safety precautions will you take?
- How will the team use and protect my personal and medical information?
Commitment
- How long will the trial last?
- Where is the trial site?
- How often will I need to travel to the site?
- How long is each visit?
- Will it involve blood draws or spinal fluid collection?
- Will I need to do anything else like fill out information online?
- Will there be reimbursement for travel or other expenses?
Before your call or visit, add any other questions you may want to ask. You can also ask the research team ahead of time if there are any questions you should ask.
Making the Decision
Once you've identified a specific trial or study and the study team has answered all your questions, they will review your medical records and confirm your eligibility for a screening visit. This visit is needed to determine your eligibility to participate in the trial.
In addition to getting input from your medical team, ALS support organization, and loved ones, it may be helpful to reflect on the following questions:
In addition to getting input from your medical team, ALS support organization, and loved ones, it may be helpful to reflect on the following questions:
- Do the potential benefits outweigh the potential drawbacks?
- Does participating align with my priorities?
- How do I feel about advancing ALS research?
- Am I able to commit to the required time?
- Will I have enough support from caregivers or others?
- Will I be able to travel to the site now and in the future?
|
|
|
The Participating in ALS Research decision tool, developed by the Les Turner ALS Foundation and NEALS, can help you determine if participating in research is right for you. It guides you through a series of questions and provides more information about ALS research.
If you are interested in and eligible for a specific clinical trial, ALS professionals often recommend enrolling rather than waiting for a better one to come along because trial eligibility and availability can be limited.
If you are interested in and eligible for a specific clinical trial, ALS professionals often recommend enrolling rather than waiting for a better one to come along because trial eligibility and availability can be limited.
Additional Resources
- The ALS Trial Navigator FAQ page goes into greater depth on many frequently asked questions about clinical trials.
- For questions about how to navigate the ALS Trial Navigator or how to enroll in a study, you can contact the NEALS Clinical Trial Liaison at [email protected].
- The ALS Research Access Nurses, Judi Carey and Kiersten Pease, at the Sean M. Healey & AMG Center for ALS, can help you better understand your options and make the best choice for you. You can reach them by emailing [email protected] or calling (617) 724-8995.
- The North Star Prism webinar series helps people living with ALS navigate research opportunities, understand clinical trials, and make informed decisions.
