NCT04561466

Trial of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy

Study of Efficacy of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Hôpital Necker-Enfants Malades · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations

Detailed description

Study of the efficiency of Béfizal® 200 mg in 14 adult patients in whom the diagnosis of LHON obtained on anamnestic, clinical and ancillary testing / laboratory data. LHON should have occurred for less than 5 years and must be genetically proved with a 3460 or 11778 mitochondrial DNA mutation. Given the mode of transmission, genetic research may have been carried out in a maternal relative

Conditions

• Safety Issues
• Efficacy, Self

Interventions

Type	Name	Description
DRUG	Béfizal	600 mf befizal a day for one year

Timeline

• Start date: 2019-03-26
• Primary completion: 2022-12-09
• Completion: 2023-03-10
• First posted: 2020-09-23
• Last updated: 2023-09-22

Locations

1 site across 1 country: France