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Phase 2 study of TAK-831 (Takeda)

Description: FARA is announcing open enrollment for a Phase 2 study of TAK-831, sponsored by Takeda. This study will evaluate safety, tolerability, pharmacokinetics and efficacy of multiple doses of TAK-831 in adults with FA. Specifically, this study will look at upper limb motor function and manual dexterity of people who take TAK-831. The study will enroll 65 participants. Participants will be randomly assigned in a 2:1:2 ratio to one of the three treatment groups: TAK-831 high dose, TAK-831 low dose and placebo. Treatment duration is 3 months.

Key Criteria: Adults ages 18-55 years with genetically confirmed FA (homozygous for GAA repeat expansion or compound heterozygous with a point mutation). Must be able to complete the nine-hole pegboard test in less than 150 seconds. For more information on inclusion and exclusion criteria, please contact one of the study site coordinators.

Study Flyer: Click HERE to view the Takeda Study Flyer.

Locations: This study is taking place at several medical centers in the United States.

Children's Hospital of Philadelphia, PA - View the CHOP Study Flyer
Contacts: McKenzie Wells, 267-426-9608 -
or Maya Patel, 267-426-7584 -

University of Iowa, Iowa City, IA
Contact: Carrie Stephan, 319-356-2673 -

University of California Los Angeles, CA
Contact: Aaron Fisher, 310-206-8153 -
or Arjun Sarkar -

University of South Florida, Tampa FL
Contact: Daniel Ekberg, 813-974-5909 -

Ohio State University, Columbus, OH
Contact: Tabi Alexander, 614-293-6953 -

University of Florida, Gainesville, FL
Contact: Blake Meyer, (352) 294-8754 -

Learn more: Here is a brief video where Kyle Bryant talks with Dr. Hao Wang about Takeda, TAK-831 and this study. posting -

Part 2 of the Phase II MOXIe study (RTA 408 or omaveloxolone)

Description: FARA is excited to share news that Part 2 of the Phase II MOXIe study (RTA 408 or omaveloxolone), sponsored by Reata, is open, and needs 100 individuals with FA to participate. This is a randomized, placebo-controlled, double-blind, parallel-group study to evaluate the safety and efficacy of omaveloxolone (RTA 408) 150 mg in patients with Friedreich's ataxia. Participants will be randomized 1:1 to either receive omaveloxolone (RTA 408) 150 mg or placebo.

Key Criteria: Please see the study flyer below to learn about Inclusion and Exclusion Criteria.

Location: This is an international study with sites in the United States, Europe, and Australia.

Latest Friedreich's Ataxia - MOXIe Study Update:

Webinar with Dr. Colin Meyer of Reata and FARA reviewing MOXIe Part 1 study results and plan for Part 2 of the study:

Please review the study flyer below, if you are interested in the study or have questions about the study, we encourage you identify the site that is geographically closest to you and contact the study coordinator.

Can't see this document? Click Me



Magnetic Resonance Imaging (MRI) Muscle Phenotyping in Mitochondrial Disease

Description: The purpose of the study is to use a new research imaging technique, a kind of magnetic resonance imaging (MRI), to measure important metabolic features of muscle, including mitochondrial function, in people with mitochondrial disease and in healthy individuals.

Key Criteria: Ages 18-65 years

Location: University of Pennsylvania -

It is hoped that this new strategy will help physicians to understand better the health problems of people with mitochondrial disease. Eventually, this could lead to better diagnostic and treatment approaches.




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