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

Primary Purpose

Leber's Hereditary Optic Neuropathy

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Idebenone
Placebo
Sponsored by
Santhera Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Leber's Hereditary Optic Neuropathy

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Idebenone

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 16, 2011
    Last Updated
    August 21, 2014
    Sponsor
    Santhera Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01495715
    Brief Title
    Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Santhera Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leber's Hereditary Optic Neuropathy

    7. Study Design

    Study Phase
    Phase 3
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Idebenone
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Idebenone
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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