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NCT02255435 · ClinicalTrials.gov registry record · Phase 2
A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 172
- Enrollment target
NCT02255435 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 172 participants.
The verdict
NCT02255435, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 172 participants
- Enrollment target
Study 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 affects physical effort, movement, coordination, and how participants feel in daily life. The main questions researchers want to answer in this study are: * How much physical effort can a participant produce during a cycling test after 12 weeks of treatment? * How do scores on the modified Friedreich's Ataxia Rating Scale (mFARS) change after 48 weeks? Researchers will use the modified Friedreich's Ataxia Rating Scale (mFARS) to measure how FA affects the nervous system. The mFARS looks at movement ability, balance, coordination, speech, and how well the arms and legs work. They will also use a cycling test to measure physical effort, along with questionnaires to learn how participants feel and function in daily life. Safety will also be tested using physical exams, vital sign checks, echocardiograms (ECHO), electrocardiograms (ECG), and blood and urine tests. The study will be done in 2 main parts, followed by an optional Extension period: * In Part 1, participants will be randomly assigned to take different doses of RTA 408 or a placebo by mouth once a day for 12 weeks. A placebo looks like the study drug but contains no real medicine. * Researchers will compare these doses to decide which one to use in Part 2. * In Part 2, a different group of participants will take either the chosen dose of RTA 408 (150 mg) or placebo once a day for 48 weeks. * Participants who complete Part 1 or Part 2 may be able to join an Extension period, where everyone receives RTA 408. * In the Extension period, participants will continue to receive RTA 408 until the drug becomes commercially available or until they leave the study * Participants in Part 1 will have up to 9 study visits and 2 phone calls. If they do not move onto the Extension period, they will stay in the study for up to
Interventions
- DRUG Placebo
- DRUG Omaveloxolone Capsules, 2.5 mg
- DRUG Omaveloxolone Capsules, 5 mg
- DRUG Omaveloxolone Capsules, 10 mg
- DRUG Omaveloxolone Capsules, 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2015-01-31 |
| Est. Completion | 2025-12-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02255435
The ClinicalTrials.gov registry entry for NCT02255435 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02255435 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02255435 about?
NCT02255435 is a clinical study titled "A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia". 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 affects physical effort, movement, coordination, and how participants feel in daily life. The main que...
What is the current status of trial NCT02255435?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 172 participants. The study started on 2015-01-31. Estimated completion is 2025-12-19.
What interventions are being tested in trial NCT02255435?
The interventions under investigation include: Placebo (DRUG), Omaveloxolone Capsules, 2.5 mg (DRUG), Omaveloxolone Capsules, 5 mg (DRUG), Omaveloxolone Capsules, 10 mg (DRUG), Omaveloxolone Capsules, 20 mg (DRUG).
Who is sponsoring clinical trial NCT02255435?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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