Trial · NCT02255422

RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR

NCT02255422, Phase 2, Completed, Biogen; results first posted 2020-09-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR. Trials, record NCT02255422. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02255422

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
NCT number: NCT02255422
Status: Completed
Phases: Phase 2
Enrollment: 53 participants, actual
Lead sponsor: Biogen
Conditions: MItochondrial Myopathies
Interventions: Omaveloxolone capsules, 2.5 mg, omaveloxolone capsules, 5 mg, omaveloxolone capsules, 10 mg, Placebo capsules, omaveloxolone capsules, 20 mg, omaveloxolone capsules, 40 mg, omaveloxolone capsules, 80 mg, omaveloxolone capsules, 160 mg
First posted: 2014-10-02
Last updated: 2025-06-05
Results first posted: 2020-09-17

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change of Peak Workload (in Watts/kg) During Exercise Testing	12 weeks	Cycle ergometry using a stationary recumbent bike was used to conduct maximal exercise testing. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion). Change of peak workload during exercise testing was measured at baseline, Week 4, and Week 12. Change from baseline at Week 12 reported.
Secondary	Change in 6-minute Walk Test (6MWT) Distance	6MWT was assessed at Week 4, Week 8, and Week 12 and compared to baseline	Patients were instructed to walk as far as they could along a marked path for 6 minutes. Distance walked was measured. If patients used a cane or walking assist device at Screening, the same walking assist device was to be used for all 6MWT assessments.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change of Peak Workload (in Watts/kg) During Exercise Testing	12 weeks	Three patients out of the 53 total were excluded from the analysis set. One each from the 20 mg arm and the 160 mg arm were excluded because they did not have post-baseline efficacy assessments. One patient from the placebo arm was excluded from analysis because their baseline maximal exercise test duration \< 4 min and was not considered valid.	Watts/kg	LEAST_SQUARES_MEAN
SECONDARY	Change in 6-minute Walk Test (6MWT) Distance	6MWT was assessed at Week 4, Week 8, and Week 12 and compared to baseline	Three patients out of the 53 total were excluded from the analysis set. One each from the 20 mg arm and the 160 mg arm were excluded because they did not have post-baseline efficacy assessments. One patient from the placebo arm was excluded from analysis because their baseline maximal exercise test duration \< 4 min and was not considered valid.	Meters	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change of Peak Workload (in Watts/kg) During Exercise Testing	Placebo		0.0090	Standard Error 0.0388	Watts/kg
Change of Peak Workload (in Watts/kg) During Exercise Testing	Omaveloxolone Capsules 2.5 and 5 mg		0.020	Standard Error 0.0544	Watts/kg
Change of Peak Workload (in Watts/kg) During Exercise Testing	Omaveloxolone Capsules 10 mg		-0.0300	Standard Error 0.0544	Watts/kg
Change of Peak Workload (in Watts/kg) During Exercise Testing	Omaveloxolone Capsules 20 mg		0.1050	Standard Error 0.0596	Watts/kg
Change of Peak Workload (in Watts/kg) During Exercise Testing	Omaveloxolone Capsules 40 mg		-0.0520	Standard Error 0.0544	Watts/kg
Change of Peak Workload (in Watts/kg) During Exercise Testing	Omaveloxolone Capsules 80 mg		-0.0660	Standard Error 0.0544	Watts/kg
Change of Peak Workload (in Watts/kg) During Exercise Testing	Omaveloxolone Capsules 160 mg		0.0020	Standard Error 0.0465	Watts/kg
Change in 6-minute Walk Test (6MWT) Distance	Placebo	Week 4	40.462	Standard Error 10.0539	Meters
Change in 6-minute Walk Test (6MWT) Distance	Omaveloxolone Capsules 2.5 and 5 mg	Week 4	19.333	Standard Error 14.9658	Meters
Change in 6-minute Walk Test (6MWT) Distance	Omaveloxolone Capsules 10 mg	Week 4	18.2500	Standard Error 14.9658	Meters

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	13
Overall Study	STARTED	Omaveloxolone Capsules 2.5 and 5 mg	6
Overall Study	STARTED	Omaveloxolone Capsules 10 mg	6
Overall Study	STARTED	Omaveloxolone Capsules 20 mg	6
Overall Study	STARTED	Omaveloxolone Capsules 40 mg	6
Overall Study	STARTED	Omaveloxolone Capsules 80 mg	6
Overall Study	STARTED	Omaveloxolone Capsules 160 mg	10
Overall Study	COMPLETED	Placebo	13
Overall Study	COMPLETED	Omaveloxolone Capsules 2.5 and 5 mg	6
Overall Study	COMPLETED	Omaveloxolone Capsules 10 mg	5

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events791

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Tachycardia	Cardiac disorders	Placebo	1	13
other	Tachycardia	Cardiac disorders	Omaveloxolone Capsules 2.5 and 5 mg	0	6
other	Tachycardia	Cardiac disorders	Omaveloxolone Capsules 10 mg	0	6
other	Tachycardia	Cardiac disorders	Omaveloxolone Capsules 20 mg	0	6
other	Tachycardia	Cardiac disorders	Omaveloxolone Capsules 40 mg	0	6
other	Tachycardia	Cardiac disorders	Omaveloxolone Capsules 80 mg	0	6
other	Tachycardia	Cardiac disorders	Omaveloxolone Capsules 160 mg	1	10
other	Ear congestion	Ear and labyrinth disorders	Placebo	0	13
other	Ear congestion	Ear and labyrinth disorders	Omaveloxolone Capsules 2.5 and 5 mg	0	6
other	Ear congestion	Ear and labyrinth disorders	Omaveloxolone Capsules 10 mg	1	6

1 to 10 of 791Source ClinicalTrials.gov

See all 791 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	13
Total, all-cause mortality	Omaveloxolone Capsules 2.5 and 5 mg	0	6
Total, all-cause mortality	Omaveloxolone Capsules 10 mg	0	6
Total, all-cause mortality	Omaveloxolone Capsules 20 mg	0	6
Total, all-cause mortality	Omaveloxolone Capsules 40 mg	0	6
Total, all-cause mortality	Omaveloxolone Capsules 80 mg	0	6
Total, all-cause mortality	Omaveloxolone Capsules 160 mg	0	10
Total, other adverse events	Placebo	11	13
Total, other adverse events	Omaveloxolone Capsules 2.5 and 5 mg	4	6
Total, other adverse events	Omaveloxolone Capsules 10 mg	6	6

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31896620	DERIVED

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02255422

GET https://conductscience.org/api/trials/v1/NCT02255422/results?page=2

API reference For AI assistants