this came across my desk this morning...
cheers
Laurel
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Idebenone Well Tolerated in Patients With Friedreich's Ataxia: Presented
at ENS
By Judith Moser, MD
MILAN, Italy -- June 25, 2009 -- In patients with the rare autosomal
recessive disorder Friedreich's ataxia (FRDA), idebenone is generally
well tolerated, according researchers here at the 19th Meeting of the
European Neurological Society (ENS).
Principal investigator Jörg B. Schulz, MD, Department of Neurology,
University Medical Center Aachen, Aachen, Germany, presented the results
of a blinded interim analysis of the first phase 3 trial conducted in
Europe to evaluate a potential treatment for this disease on June 23.
As Dr. Schulz explained, the randomised, placebo-controlled,
double-blind, 12-month, multicentre phase 3 Mitochondrial Protection
With Idebenone in Cardiological or Neurological Outcome Study (MICONOS)
is being conducted to further evaluate the efficacy and safety of
idebenone in children and adults with FRDA based on phase 2 data.
A total of 232 patients aged >=8 years at baseline with a diagnosis of
FRDA and confirmed FRDA mutations are participating.
The patients were randomised to idebenone 180 or 360 mg/day (depending
on body weight), 450 or 900 mg/day, or 1,350 or 2,250 mg/day or placebo.
The threshold regarding body weight was 45 kg.
"It has been shown before that even higher doses are safe in the
treatment of FRDA," Dr. Schulz stressed.
Source/read more:
http://www.docguide.com/news/content.nsf/news/852571020057CCF6852575E100649CE8
Article kindly supplied by Mari Luz González Casas
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