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A randomized placebo-controlled trial of idebenone in Leber’s hereditary optic neuropathy

July 23, 2011

Clinical trial

A randomized placebo-controlled trial of idebenone in Leber’s hereditary optic neuropathy.

Klopstock T, Yu-Wai-Man P, Dimitriadis K, Rouleau J, Heck S, Bailie M, Atawan A, Chattopadhyay S, Schubert M, Garip A, Kernt M, Petraki D, Rummey C, Leinonen M, Metz G, Griffiths PG, Meier T, Chinnery PF.

Brain. 2011 Sep;134(Pt 9):2677-86.
Full text | Metrics.

Main finding: Idebenone provided significant improvement in visual acuity over placebo in patients with discordant visual acuities between both eyes at baseline.

 

  • Purpose: To study the use of idebenone in Leber’s hereditary optic neuropathy
  • Study type: Randomized controlled trial
  • Condition: Leber’s hereditary optic neuropathy

Participants: 14-64yo with LHON.
Mitochondrial mutations: m.3460G>A, m.11778G>A, or m.14484T>C

 

  • n=85

 

Intervention:

 

Group 1: Idebenone (300mg tds)
Group 2: Placebo

There was no significant difference between both groups in best recovery in visual acuity.
A post hoc analysis showed a significant difference in a subset of patients with discordant visual acuities (interocular acuity discordance of logMAR >0.2) at baseline in:
-changes visual acuity of the best eye at baseline
-changes in visual acuity for both eyes in each patient

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