Centre Hospitalier Regional D'Angers
Angers, France
Not recruitingOptic atrophy
Study on the Safety and Effects of Nicotinamide for Patients with Dominant Optic Atrophy
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a condition called Dominant Optic Atrophy (DOA), which affects the eyes and can lead to vision loss. The study will use a treatment called nicotinamide, also known as vitamin B3, which will be given in the form of a film-coated tablet called NICOBION 500 mg. The main goal of the study is to evaluate the safety of taking 3 grams of nicotinamide daily in patients with DOA to ensure it does not cause harmful effects on the eyes or nervous system.
Participants in the study will take the medication orally, meaning they will swallow the tablets. The study will last for several months, during which participants will have regular follow-up visits. These visits will help researchers monitor any changes in vision and check for any side effects. The study will also measure the levels of nicotinamide in the blood to see how the body processes the treatment.
Throughout the study, researchers will look for any improvements in visual function and overall neurological health. They will also use a specific questionnaire, the NEI-VFQ-25, to assess the impact of the treatment on participants' quality of life. The study aims to provide valuable information on the potential benefits and safety of nicotinamide for individuals with Dominant Optic Atrophy.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Participants must be adults.
- Participants must have **Dominant Optic Atrophy (DOA)** or **DOA+**, which is a condition caused by a specific change in the **OPA1 gene**.
- Participants must not have taken **nicotinamide** for more than 3 months before the study. **Nicotinamide** is a form of vitamin B3.
- Participants must be able to take medicine by mouth and follow the study's specific procedures.
- Participants must be part of or have access to a social security system.
- Participants must sign a consent form, which means they agree to join the study voluntarily and understand what it involves.
Who cannot join the trial?
9 criteria
- Patients who are not diagnosed with Dominant Optic Atrophy (a condition affecting the eyes).
- Patients who are younger than 4 years old or older than 18 years old.
- Patients who are part of a vulnerable population, which means they might need special protection or care.
- Patients who cannot tolerate 3 grams per day of nicotinamide (a form of vitamin B3).
- Patients who have any other medical conditions that might interfere with the study.
- Patients who are pregnant or breastfeeding.
- Patients who are currently participating in another clinical trial.
- Patients who have a history of severe allergic reactions to any of the study medications.
- Patients who have any serious health issues that could affect their participation in the study.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
Nicotinamide: This is a form of vitamin B3 used in the trial to assess its safety and effectiveness in patients with Dominant Optic Atrophy (DOA). The study aims to determine if taking nicotinamide daily is well-tolerated and does not cause harmful effects on the eyes or nervous system.
What is already known about the treatment
Nicotinamide – Nicotinamide, also known as vitamin B3, is administered orally in the form of tablets. It is currently being studied in clinical trials for its safety and effectiveness in treating Dominant Optic Atrophy (DOA). The main therapeutic indication for nicotinamide in this context is to improve visual function in patients with DOA. At the molecular level, nicotinamide works by supporting cellular energy production and reducing oxidative stress, which may help protect optic nerve cells. It is classified pharmacologically as a vitamin and a dietary supplement.
Investigated diseases
Dominant Optic Atrophy – Dominant Optic Atrophy is a genetic condition that primarily affects the eyes, leading to a gradual loss of vision. It typically begins in childhood and is characterized by the degeneration of the optic nerves, which carry visual information from the eyes to the brain. Individuals with this condition often experience a slow decline in visual acuity, color vision defects, and a narrowing of the visual field. The progression of vision loss can vary widely among affected individuals, with some maintaining relatively good vision while others may experience significant impairment. The condition is inherited in an autosomal dominant pattern, meaning one copy of the altered gene in each cell is sufficient to cause the disorder.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506214-52-00Estimated enrolment25 patientsSponsorCentre Hospitalier Universitaire D'Angers
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?