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Trial · NCT00747487

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryBest recovery of logMAR visual acuity between baseline and Week 24 in either right or left eye24 weeks
SecondaryChange in the patient's best logMAR visual acuity between baseline and week 2424 weeks
SecondaryChange in scotoma area in both eyesDay -1, Week 4, Week 12, Week 24
SecondaryChange in optic nerve fibre layer thickness in both eyesDay -1, Week 4, Week 12, Week 24
SecondaryColour contrast sensitivity in both eyes (in a subset of patients)Day -1, Week 4, Week 12, Week 24
SecondarylogMAR visual acuity as a continuous variable in both eyesScreening, Day -1, Week 4, Week 12, Week 24, Week 28
SecondaryClinical Global Impression of ChangeWeek 4, Week 12 and Week 24
SecondaryChange in Health-Related Quality of Life (HRQOL)Day -1, Week 4, Week 12, Week 24
SecondaryChange in self-reported general energy levelsDay -1, Week 4, Week 12, Week 24, Week 28
Secondary
Proportion of patients in which visual acuity in the initially least affected eye does not deteriorate to 1.0 log MAR or more ( in LHON patients with eye still less affected than 0.5 logMAR at trial entry)
24 weeks
SecondaryPlasma levels of idebenone matched to measures of efficacy and safety24 weeks
Secondary• Best visual acuity at Week 24 (best eye at Week 24) compared to best visual acuity at Baseline (best eye at Baseline)24 weeks
Secondary• Count of eyes/ patients for which the visual acuity improves between baseline and week 2424 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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