Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is meant to assess the effectiveness of idebenone on visual function measures in patients with Leber's Hereditary Optic Neuropathy over a 6 months period.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study

NCT04381091

Leber's Hereditary Optic Neuropathy

NO_LONGER_AVAILABLE

Study to Assess the Efficacy and Safety of Raxone in LHON Patients

NCT02774005

Leber's Hereditary Optic Neuropathy (LHON)

COMPLETED PHASE4

Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

NCT02151695

Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

COMPLETED PHASE2

Phenotyping Diabetic Retinopathy

NCT00840541

Diabetic Retinopathy

COMPLETED

A Study to Learn More About the Use of Aflibercept in Routine Medical Practice in Japanese Participants With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema

NCT06929143

Neovascular Age-related Macular Degeneration (nAMD) Diabetic Macular Edema (DME)

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study involves 6 clinic visits.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leber's Hereditary Optic Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Idebenone

Group Type EXPERIMENTAL

Idebenone

Intervention Type DRUG

Idebenone 900 mg/day

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Idebenone

Idebenone 900 mg/day

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \> or = 14 years and \< 65 years
* Impaired visual acuity in at least one eye due to LHON
* Onset of visual loss due to LHON lies five years or less prior to Baseline
* Confirmation of either G11778A, T14484C or G3460A LHON mtDNA mutations at \>60% in blood
* No explanation for the visual failure besides LHON
* Body weight ≥ 45 kg
* Negative urine pregnancy test at Screening and at Baseline (women of childbearing potential).

Exclusion Criteria

* Treatment with Coenzyme Q10 or idebenone within 1 month prior to Baseline
* Pregnancy and/or breast-feeding
* Weekly alcohol intake 35 units (men) or 24 units (women)
* Current drug abuse
* Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine
* Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
* Other factor that, in the investigator's opinion, excludes the patient from entering the study

Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No