Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia
Lead Sponsor:
Biogen
Collaborating Sponsors:
AbbVie
Friedreich's Ataxia Research Alliance
Conditions:
Friedreich Ataxia
Eligibility:
All Genders
16-40 years
Phase:
PHASE2
Brief Summary
In this study, researchers are learning more about RTA 408, also known as omaveloxolone, BIIB141, or SKYCLARYS®. The main goal of this study is to learn more about the safety of RTA 408 and how it aff...
Detailed Description
Friedreich's ataxia is an autosomal recessive cerebellar ataxia caused by triplet-repeat expansions. The causative mutation is a trinucleotide (GAA) repeat expansion in the first intron of the frataxi...
Eligibility Criteria
Inclusion
- Have genetically confirmed Friedreich's ataxia
- Have a modified FARS score ≥20 and ≤80
- Be male or female and ≥16 years of age and ≤40 years of age
- Have no changes to exercise regimen within 30 days prior to Study Day 1 and be willing to remain on the same exercise regimen during the 16-week study period
- Have the ability to complete maximal exercise testing
- Be able to swallow capsules
Exclusion
- Have uncontrolled diabetes (HbA1c \>11.0%)
- Have B-type natriuretic peptide value \>200 pg/mL
- Have a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease
- Have known active fungal, bacterial, and/or viral infection, including human immunodeficiency virus or hepatitis virus (B or C)
- Have known or suspected active drug or alcohol abuse
- Have clinically significant abnormalities of clinical hematology or biochemistry, including but not limited to elevations greater than 1.5 times the upper limit of normal of aspartate aminotransferase, or alanine aminotransferase
- Have any abnormal laboratory test value or serious pre-existing medical condition that, in the opinion of the investigator, would put the patient at risk by study enrollment
- Have taken any of the following drugs within 7 days prior to Study Day 1 or plan to take any of these drugs during the time of study participation:
- Sensitive substrates for cytochrome P450 2C8 or 3A4 (e.g., repaglinide, midazolam, sildenafil)
- Moderate or strong inhibitors or inducers of cytochrome P450 3A4 (e.g., carbamazepine, phenytoin, ciprofloxacin, grapefruit juice)
- Substrates for p-glycoprotein transporter (e.g., ambrisentan, digoxin)
- Have participated in any other interventional clinical study within 30 days prior to Study Day 1
- Have a cognitive impairment that may preclude ability to comply with study procedures
- Prior participation in a trial with omaveloxolone (RTA 408)
Key Trial Info
Start Date :
January 31 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT02255435
Start Date
January 31 2015
End Date
December 31 2025
Last Update
December 31 2025
Active Locations (11)
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1
UCLA
Los Angeles, California, United States, 90095
2
University of Florida - Neurology
Gainesville, Florida, United States, 32610
3
USF Ataxia Research Center
Tampa, Florida, United States, 33612
4
Emory University Hospital - Neurology
Atlanta, Georgia, United States, 30329