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BIOtinidase Test In Optic-Neuropathy (BIOTIN)

F

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Conditions

Biotin Deficiency
Optic Neuropathy

Study type

Observational

Funder types

NETWORK

Identifiers

NCT03268681
RDS_2017_14

Details and patient eligibility

About

Biotinidase is an enzyme that recycles biotin, a water-soluble vitamin essential as a coenzyme for four carboxylases that are involved in gluconeogenesis, fatty acid synthesis, and in the catabolism of several branch-chain amino acids. Biotinidase deficiency (BD) is an autosomal recessively inherited disorder. Patients with profound BD (<10% of mean normal serum biotinidase activity) presents, usually during early childhood, with neurological (seizures, hypotonia, ataxia, developmental delay, vision problems, and/or hearing loss) and non-neurological findings (metabolic acidosis, respiratory difficulties, alopecia and/or skin rash) that may progress to coma or death if untreated.

Three cases of adult-onset biotinidase deficiency with reversible optic neuropathy have recently been described in France, where there is no neonatal screening of BP. Once treated with Biotin, patients' vision was fully restored.

This study aims to assess the prevalence of BP among a population of patients with idiopathic optic neuropathy, and to assess the efficacy of Biotin supplementation on visual impairment in these patients.

Enrollment

12 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patient with bilateral optic neuropathy
  • symptoms beginning before 50 years old
  • diagnosed for more than 1 months
  • etiology unknown

Exclusion criteria

  • none

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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