ALS Clinical Trials

ALS (Lou Gehrig’s Disease) Clinical trial

Have you ever lived in Kentucky, West Virginia, Tennessee, Ohio, or Indiana? Do you have ALS?

If the answer to these questions is YES, then we need you to help answer the question, “What causes ALS?”. You and your family can help with an important research project.

One question from almost every ALS patient is “What causes ALS?” and “Is there something in the environment that caused my ALS?”. The answers to these questions are not known. Many experts believe that there might be some environmental exposure that contributes to the development of ALS.

At the ALS Center at the University of Kentucky, we are trying to find out the answers to these questions by learning exactly where ALS patients lived during their entire life. In this way, we will be able to determine if there is something in common at some point in time before a patient developed their ALS. We call this our Residential Survey Project. To do this, we need every ALS patient who lived in Kentucky, West Virginia, Tennessee, Ohio, or Indiana at some point in their lives to come forward and participate.

 

What can you do to help?

Volunteer for the study by contacting our ALS Center through Jessica Carpenter at 859-218-5061 or by email (jdcumm0@email.uky.edu) or Kathie Vanderpool at 859-218-5064 (kvander@email.uky.edu). She will send you a research consent form that explains the study and asks for your participation.

After we get the signed consent form, we will send you a copy of the Residential Survey. This will ask you to write down the exact location of each place that you lived since birth. This can be a house address if you lived in a city or a description of a place you might have lived in the country. Basically, give directions to the house where you lived. Also the time you resided at each place. This usually is a fun, family activity trying to reconstruct the moving from one place to another over your lifetime.

Send the completed form back to us in a stamped envelope that we will provide. We will probably have to call you if we have questions after we review your information.

Don’t worry if you have not been treated as a patient at our ALS Center at the University of Kentucky. This study is for everyone in these states.

Current ALS Research Studies

Clinical Drug Studies

  • The CENTAUR study sponsored by Amylyx Pharmaceuticals and Massachusetts General Hospital – In this Phase II study, we are looking at two drugs that have previously been tested in individuals with ALS and showed some promise. The goal of this study is to see whether the combined effect of both drugs can slow down the progression of ALS. It is administered orally. We are currently ENROLLING for this study.

  • The PENNANT study sponsored by Mallinckrodt Pharmaceuticals – In this Phase II study, we are asking individuals with ALS to administer a corticosteroid subcutaneously (injection under the skin). This is another study where the goal is to see whether or not this investigational drug can help slow down ALS progression. We are currently ENROLLING for this study.

  • TRANSLATE – Only open to individuals who have a known mutation in the FUS gene and ALS and/or their family members. In this study, we are looking to see whether or not the administration of an intramuscular injection of betamethasone can help reduce oxidative stress. We are currently ENROLLING for this study.

  • REFALS sponsored by Orion Pharmaceuticals – University of Kentucky has recently been selected as site for this Phase III study with potential start date in late 2018.

Investigator-Initiated Studies

  • DNA Banking and FUS Gene Research – Patients and their family members who are identified to be likely to have a specific genetic mutation may offer blood samples and/or skin biopsy samples for Dr. Kasarskis and his research team to study to learn more about the way that genetic mutation causes disease. The ultimate goal would be to determine a way to turn off the genetic mutation that causes disease; and/or to prevent the development of the disease when someone gets the genetic mutation.
  • Sialorrhea (drooling) Study with Radiation Medicine – Dr. Kasarskis and his research team are evaluating the effectiveness of Electron Beam Radiation in decreasing saliva production to improve the troublesome symptom of sialorrhea (excessive saliva) in patients with ALS and other debilitating neurological disorders.
  • Residential Survey of ALS Patients living in KY, OH, WV, TN, and IN – Dr. Kasarskis and his research team are looking for environmental factors that are associated with an increased risk for developing ALS. Willing participants are asked to complete a survey that includes their lifelong residential and occupational history (every place they have lived, and their occupation while they lived there). This study is open to all ALS patients.
  • AWARE Quality of Life Study – Dr. Debra Suiter, PhD, Speech Language Pathologist at UK ALS Center, is conducting a clinical observational study to examine the quality of life of patients with swallowing problems related to ALS and their caregivers.

Contacts

Please feel free to call at any time regarding ALS Clinical Trials!

University of Kentucky ALS Center
Kentucky Clinic – Kentucky Neuroscience Institute
740 S. Limestone Street, J-401
Lexington, Ky 40536-0284

 

Edward J. Kasarskis, MD, PhD
Neurologist / Principal Investigator
E-mail:edward.kasarskis@uky.edu
 

Meha Joshi, BA
Clinical Research Coordinator
Office Phone: (859) 218-5046
Office Fax: (859) 257-8990
E-mail: majo235@uky.edu


Meghann Bruno, RN, BSN
Clinical Research Nurse
Office Phone: (859) 218-5064
Office Fax: (859) 257-8990
E-mail: meghann.bruno@uky.edu