Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)

August 21, 2014 updated by: Santhera Pharmaceuticals
The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > or equal 10 years and < 65 years
  • Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR
  • No explanation for visual loss besides LHON

Exclusion Criteria:

  • Any previous use of idebenone
  • Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
  • Previous participation in Study SNT-II-003 (RHODOS) for idebenone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: Idebenone
Drug: Idebenone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santhera Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (ESTIMATE)

December 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 21, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNT-III-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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