Trial · NCT00887562

Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes

NCT00887562, Phase 2, Completed, Michio Hirano; results first posted 2016-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes. Trials, record NCT00887562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00887562

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Trial

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

Title: Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes
NCT number: NCT00887562
Status: Completed
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: Michio Hirano
Conditions: MELAS Syndrome
Interventions: Idebenone, Idebenone, Placebo
First posted: 2009-04-24
Last updated: 2016-10-26
Results first posted: 2016-08-10
Limitations and caveats: Clinical variability in severity of disease among participants

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy)	Up to 4 weeks from baseline	To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on cerebral lactate concentration as measured by magnetic resonance spectroscopy (MRS)
Secondary	Mean Change in Venous Lactate Concentration	Up to 4 weeks from baseline	To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on venous lactate concentration
Secondary	Mean Change in Score on the Fatigue Severity Scale (FSS)	Baseline and Week 4	To assess changes following 1 month treatment with 2 different doses of idebenone with that of placebo in fatigue as assessed by the Fatigue Severity Scale (FSS). Scale score minimum is 9 (least fatigue) and maximum is 63 (maximum fatigue). Scores of 36 or less indicate possibility that patient may not be suffering from fatigue, while scores 36 and over suggest suffering from fatigue

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy)	Up to 4 weeks from baseline	IU	MEAN
SECONDARY	Mean Change in Venous Lactate Concentration	Up to 4 weeks from baseline	mM/L	MEAN
SECONDARY	Mean Change in Score on the Fatigue Severity Scale (FSS)	Baseline and Week 4	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy)	Idebenone 900 mg/Day	-0.09	Standard Deviation 0.95	IU
Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy)	Idebenone 2250 mg/Day	0.16	Standard Deviation 1.49	IU
Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy)	Placebo	-0.49	Standard Deviation 1.18	IU
Mean Change in Venous Lactate Concentration	Idebenone 900 mg/Day	-0.24	Standard Deviation 1.18	mM/L
Mean Change in Venous Lactate Concentration	Idebenone 2250 mg/Day	0.7	Standard Deviation 1.31	mM/L
Mean Change in Venous Lactate Concentration	Placebo	-0.46	Standard Deviation 1.07	mM/L
Mean Change in Score on the Fatigue Severity Scale (FSS)	900 mg/Day	-3.8	Standard Deviation 11	units on a scale
Mean Change in Score on the Fatigue Severity Scale (FSS)	2250 mg/Day	-1.3	Standard Deviation 10	units on a scale
Mean Change in Score on the Fatigue Severity Scale (FSS)	Placebo	4.3	Standard Deviation 4.5	units on a scale

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Idebenone 900 mg/Day	10
Overall Study	STARTED	Idebenone 2250 mg/Day	9
Overall Study	STARTED	Placebo	8
Overall Study	COMPLETED	Idebenone 900 mg/Day	7
Overall Study	COMPLETED	Idebenone 2250 mg/Day	7
Overall Study	COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Idebenone 900 mg/Day	3
Overall Study	NOT COMPLETED	Idebenone 2250 mg/Day	2
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events147

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	Events
other	abdominal discomfort	Gastrointestinal disorders	Idebenone 900 mg/Day	0	10	0
other	abdominal discomfort	Gastrointestinal disorders	Idebenone 2250 mg/Day	0	9	0
other	abdominal discomfort	Gastrointestinal disorders	Placebo	2	8	2
other	abdominal distention	Gastrointestinal disorders	Idebenone 900 mg/Day	1	10	1
other	abdominal distention	Gastrointestinal disorders	Idebenone 2250 mg/Day	2	9	2
other	abdominal distention	Gastrointestinal disorders	Placebo	1	8	2
other	abdominal pain	Gastrointestinal disorders	Idebenone 900 mg/Day	1	10	2
other	abdominal pain	Gastrointestinal disorders	Idebenone 2250 mg/Day	1	9	2
other	abdominal pain	Gastrointestinal disorders	Placebo	0	8	0
other	constipation	Gastrointestinal disorders	Idebenone 900 mg/Day	1	10	1

1 to 10 of 147Source ClinicalTrials.gov

See all 147 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Idebenone 900 mg/Day
Total, all-cause mortality	Idebenone 2250 mg/Day
Total, all-cause mortality	Placebo
Total, other adverse events	Idebenone 900 mg/Day	10	10
Total, other adverse events	Idebenone 2250 mg/Day	9	9
Total, other adverse events	Placebo	8	8
Total, serious adverse events	Idebenone 900 mg/Day	0	10
Total, serious adverse events	Idebenone 2250 mg/Day	0	9
Total, serious adverse events	Placebo	0	8

Source ClinicalTrials.gov

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.

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/NCT00887562

GET https://conductscience.org/api/trials/v1/NCT00887562/events?page=2

API reference For AI assistants