Trial · NCT06623890
A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own Doctors
NCT06623890, Recruiting, Biogen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own Doctors. Trials, record NCT06623890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06623890
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own Doctors
- NCT number
- NCT06623890
- Status
- Recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Biogen
- Conditions
- Friedreich Ataxia
- Interventions
- Omaveloxolone
- First posted
- 2024-10-02
- Last updated
- 2026-04-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Omaveloxolone Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | From the start of the treatment up to end of the study (up to 5 years) | |
| Primary | Omaveloxolone Non-Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | From enrolment in the current study up to end of the study (up to 5 years) | |
| Primary | Omaveloxolone Naive Cohort: Number of Participants With DILI and CHF AEs | From the start of the treatment up to end of the study (up to 5 years) | |
| Primary | Omaveloxolone Non-Naive Cohort: Number of Participants With DILI and CHF AE | From enrolment in the current study up to end of the study (up to 5 years) | |
| Secondary | Time to Omaveloxolone Treatment Interruption | Up to 5 years | |
| Secondary | Time to Omaveloxolone Treatment Discontinuation | Up to 5 years | |
| Secondary | Time to Omaveloxolone Drug Overdose | Up to 5 years | |
| Secondary | Number of Participants With Reasons for Omaveloxolone Treatment Interruption, Treatment Discontinuation and Overdose | Up to 5 years |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06623890
GET https://conductscience.org/api/trials/v1/NCT06623890/registered