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Are you trying to understand the research study options available for ALS?

Learn about a new, investigational research study that may help manage the symptoms of ALS.


AMX0035, an oral combination of two small molecules, sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA), is now being evaluated to determine if there is an impact on ALS disease progression. Each compound has shown efficacy in several cellular and animal models of ALS. Small clinical trials have supported the potential for safety and efficacy of these compounds; however, this larger trial is needed to confirm these findings.

Right now, doctors at select centers in the U.S. are accepting ALS patients to participate in the clinical research study for AMX0035. To learn more, please fill out the application below.

About ALS

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which leads to total paralysis and death, usually within two to five years of diagnosis.

About this study

Dr. Sabrina Paganoni from Massachusetts General Hospital discusses CENTAUR,
a phase 2 trial for people with ALS.

Is AMX0035 right for me?

Who is this study for?

The staff at your clinical trial site will help determine if you meet the criteria for the study. This study is looking for individuals who are:

  • Male or female, aged 18-80 years of age
  • Have had less than or equal to 18 months since their ALS symptom onset
  • Additional criteria to be evaluated

 

What should I expect?

Participating in the study will last for approximately 30-34 weeks, and includes:

  • 24 weeks of treatment
  • Additional screening assessments, which will take up to 6 weeks
  • 4 weeks of safety follow up after the treatment is completed

 

Frequently asked questions

Will the treatment be available after the study ends?

The CENTAUR-OLE study provides patients with the option of continuing treatment once they have completed the 24-week study period.

What will this study evaluate?

The trial will evaluate AMX0035’s ability to have an impact on daily functioning, muscle strength, and respiratory function as well as its ability to alter biological markers of ALS.

25 locations

 

Barrow Neurological Institute

University of Florida Medical Center

Oregon Health & Science University

University of Massachusetts Memorial Medical Center

Ochsner Neuroscience Institute

Johns Hopkins Hospital

ALS Center at the Swedish Neuroscience Institute

The Penn Comprehensive ALS Center

Temple University Hospital

Wake Forest Baptist Medical Center

The Ohio State University Wexner Medical Center

Washington University Medical Center

UC Irvine Medical Center

University of Michigan Medical Center

Neurology Associates P.C.

Forbes Norris MDA/ALS Research Center - California Pacific Medical Center

Carol and Frank Morsini Center for Advanced Health Care - University of South Florida

Emory University Hospital

University of Kentucky Medical Center

Hennepin County Medical Center

Mount Sinai Beth Israel

Texas Neurology, P.A.

University of Texas Health Science Center at San Antonio

University of Iowa Hospitals and Clinics

Massachusetts General Hospital

 

"To accelerate developing new treatments for ALS, the two foundations issued a global, competitive call for grant proposals for therapies that had a strong scientific rationale and where a biomarker of drug effect could be measured. AMX0035 was chosen as one of the top new therapeutic candidates to bring forward for ALS."

- Merit Cudkowicz, MD, Chief Medical Officer for ALS Finding A Cure and Chief of Neurology at Massachusetts General HospitalMerit Cudkowicz

Have a question?

For more information, fill out the form, contact (617-724-7210), or email Emily Engel at eengel@partners.org