Trial · NCT00747487
Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy
NCT00747487, Phase 2, Completed, Santhera Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy. Trials, record NCT00747487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00747487
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy
- NCT number
- NCT00747487
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- Santhera Pharmaceuticals
- Conditions
- Leber's Hereditary Optic Neuropathy
- Interventions
- Idebenone, Placebo
- First posted
- 2008-09-05
- Last updated
- 2013-05-27
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best recovery of logMAR visual acuity between baseline and Week 24 in either right or left eye | 24 weeks | |
| Secondary | Change in the patient's best logMAR visual acuity between baseline and week 24 | 24 weeks | |
| Secondary | Change in scotoma area in both eyes | Day -1, Week 4, Week 12, Week 24 | |
| Secondary | Change in optic nerve fibre layer thickness in both eyes | Day -1, Week 4, Week 12, Week 24 | |
| Secondary | Colour contrast sensitivity in both eyes (in a subset of patients) | Day -1, Week 4, Week 12, Week 24 | |
| Secondary | logMAR visual acuity as a continuous variable in both eyes | Screening, Day -1, Week 4, Week 12, Week 24, Week 28 | |
| Secondary | Clinical Global Impression of Change | Week 4, Week 12 and Week 24 | |
| Secondary | Change in Health-Related Quality of Life (HRQOL) | Day -1, Week 4, Week 12, Week 24 | |
| Secondary | Change in self-reported general energy levels | Day -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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00747487
GET https://conductscience.org/api/trials/v1/NCT00747487/registered