Trial · NCT07258667
Pilot Study of the Efficacy of Nicotinamide (Vitamin B3) in Leber's Hereditary Optic Neuropathy
NCT07258667, Phase 1, Not yet recruiting, University Hospital, Angers
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of the Efficacy of Nicotinamide (Vitamin B3) in Leber's Hereditary Optic Neuropathy. Trials, record NCT07258667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07258667
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of the Efficacy of Nicotinamide (Vitamin B3) in Leber's Hereditary Optic Neuropathy
- NCT number
- NCT07258667
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 13 participants, estimated
- Lead sponsor
- University Hospital, Angers
- Conditions
- Leber Hereditary Optic Neuropathy (LHON), Leber's Hereditary Optic Neuropathy (LHON), Mitochondrial Disease, Optic Nerve Disease
- Interventions
- Nicotinamide treatment
- First posted
- 2025-12-02
- Last updated
- 2025-12-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the efficacy of administering 2 grams per day of nicotinamide for 12 months in patients who have developed NOHL due to an m.11778G>A or m.3460G>A mutation within the last 18 months. | inclusion, 3 months, 6 months, 9 months, and 12 months | Evaluation by the change in corrected distance visual acuity measured eye by eye on an ETDRS (Early Treatment Diabetic Retinopathy Study) scale over the entire follow-up period. |
| Secondary | The effectiveness of treatment on the progression of corrected distance visual acuity | 12 months | Measurement eye by eye using the ETDRS scale, taking the nadir (lowest visual acuity reached a few weeks after the onset of NOHL) as the reference value. |
| Secondary | The effectiveness of treatment on the evolution of corrected distance visual acuity | inclusion, 3 months, 6 months, 9 months and 12 months | Measurement eye by eye on a Monoyer scale. Reading capital letters at a distance of 5 meters. Each line on the wall-mounted optometric chart corresponds to 1/10 of visual acuity.The dimensions of the letters are such that they measure 5 times the distance of discrimination corresponding to the measured visual acuity.0.4/10 is low visual acuity and 20/10 is good visual acuity. |
| Secondary | The effectiveness of treatment on the evolution of corrected near visual acuity | inclusion, 3 months, 6 months, 9 months and 12 months | Measurement eye by eye on a Parinaud scale; different sizes of typeface is placed at 33cm. The test consists of a text whose paragraphs are written in decreasing font sizes. The result is expressed in P (P1.5 to P50). The higher the P, the poorer the acuity. |
| Secondary | The effectiveness of treatment on the evolution of Campimetric deficits | inclusion, 3 months, 6 months, 9 months and 12 months | The average and corrected average deviation measured in STAT 30 on an automated visual field |
| Secondary | The effectiveness of treatment on the evolution of the appearance of visual field | inclusion, 3 months, 6 months, 9 months and 12 months | By the Goldman-type manual |
| Secondary | The effectiveness of treatment on the evolution of optic nerve fiber layer (RNFL) thickness | inclusion, 3 months, 6 months, 9 months and 12 months | Measurement by optical coherence tomography (OCT) |
| Secondary | The effectiveness of treatment on the evolution of retinal ganglion cell complex (GCC) | inclusion, 3 months, 6 months, 9 months and 12 months | Measurement by optical coherence tomography (OCT) |
| Secondary | The effectiveness of treatment on the evolution of Patients' quality of life | inclusion and 12 months | NEI VFQ 25 questionnaire. Individual scores are recoded and transformed on a scale of 0 to 100, where 100 represents the best possible functioning and 0 the worst. An average score is calculated for each of the 12 subscales. |
| Secondary | Biological efficacy of treatment | 3 and 12 months | Nicotinamide levels in patients' blood |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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/NCT07258667
GET https://conductscience.org/api/trials/v1/NCT07258667/registered