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

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ClinicalTrials.gov Identifier: NCT01495715
Recruitment Status : Withdrawn
First Posted : December 20, 2011
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Santhera Pharmaceuticals

December 16, 2011
December 20, 2011
August 22, 2014
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Complete list of historical versions of study NCT01495715 on ClinicalTrials.gov Archive Site
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Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
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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.
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Interventional
Phase 3
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Leber's Hereditary Optic Neuropathy
  • Drug: Idebenone
  • Drug: Placebo
  • Experimental: Idebenone
    Intervention: Drug: Idebenone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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.
Sexes Eligible for Study: All
10 Years to 65 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01495715
SNT-III-011
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Santhera Pharmaceuticals
Santhera Pharmaceuticals
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Santhera Pharmaceuticals
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP