Skip to content

Multicenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathy

Multicenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathy - Clinical trial of Idebenone in patients with LHON

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017939
Enrollment
50
Registered
2015-06-20
Start date
2013-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leber hereditary optic neuropathy

Interventions

1. Clinical trial medicine: Idebenone 900mg/day 2. Objectives: 50 patients with LHON 3. Exclusion criteria: a) A smoker b) A patient with abnormality of hepatic function c) A patient who pre
a) At the base line: Visual acuity (VA), Critical flicker frequency (CFF), Visual field (VF: Humphry 30-2), central retinal thickness (CRT), functional MRI (f-MRI), searching the mitochondrial mutatio

Sponsors

Hyogo College of Medicine
Lead Sponsor
Kitasato University Jikei University School of Medicine Tokyo Medical University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 50 patients with LHON

Exclusion criteria

Exclusion criteria: a) A smoker b) A patient with abnormality of hepatic function c) A patient who present seizures, delirium and hallucination d) Pregnancy or Lactation e) A patient who is associated with agranulocytosis f) A patient with chronic renal failure g) A patient with anaphylactic shock against Idebenone

Design outcomes

Primary

MeasureTime frame
Visual acuity (at 12 months after the start of the study drug)

Secondary

MeasureTime frame
Visual acuity (at 6 months after the start of the study drug), Visual field (at 6 and 12 months after the start of the study drug), Critical flicker frequency (at 6 and 12 months after the start of the study drug), central retinal thickness (at 6 and 12 months after the start of the study drug)

Countries

Japan

Contacts

Public ContactHiroto Ishikawa

Hyogo College of Medicine Ophthalmology

ohmyeye@hyo-med.ac.jp0798-45-6462

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026