Minocycline Has Harmful Effect on Patients With Motor Neuron Disease
- From: "Shelley" <noway@xxxxxxxxx>
- Date: Fri, 2 Nov 2007 13:11:38 -0400
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Minocycline Has Harmful Effect on Patients With Motor Neuron Disease
LONDON, U.K. -- November 1, 2007 -- Minocycline has a harmful effect
on patients with amyotrophic lateral sclerosis (ALS) -- commonly
known as motor neuron disease or Lou Gehrig's disease -- according to
one of the first randomised trials of the drug in patients with a
neurological disorder.
This finding has implications for several trials that are planned or
in progress for minocycline in patients with Huntington's disease,
stroke, dementia, and multiple sclerosis, according to an Article in
The Lancet Neurology to be published Online, Thursday, November 1, 2007.
Minocycline is an off-the shelf anti-inflammatory and anti-apoptotic
drug that is neuroprotective in animal models of stroke, trauma, and
neurodegenerative disorders, and also prolongs survival and reduces
motor neuron loss in transgenic mouse models of ALS. Phase II trials
suggested that minocycline could be taken safely by patients with
ALS. On the basis of these positive results plans were made for many
trials of minocycline in neurodegenerative conditions.
Dr. Paul H Gordon, Columbia University, New York, USA, and colleagues
in the United States Western ALS Study Group did a randomised phase
III trial to test the efficacy of minocycline as a treatment for ALS
in 412 patients. Compared with patients who took placebo, minocycline-
treated patients deteriorated at a 25% faster rate according to the
ALS functional rating scale (ALSFRS-R), and showed non-significant
tendencies towards faster decline of forced vital capacity (FVC) and
muscle strength.
In light of these findings, the authors suggest that trials of
minocycline in other neurological diseases should be reassessed, as
minocycline might be detrimental in patients with neurological
diseases other than ALS. They conclude: "Our results are contrary to
many published reports from laboratories, and thus have implications
for trials of minocycline in patients with other neurological
conditions, for the preclinical evaluation of potential
neuroprotective therapies, and for the design of future clinical
trials in ALS".
In an accompanying Comment Dr Michael Swash highlights the need for
early diagnosis in ALS: "Clinicians and patients alike would prefer
ALS therapy to be tested as early as possible, but there are
unresolved difficulties with accurate early diagnosis, particularly
the absence of a specific diagnostic test. Might some of the
compounds that have failed in clinical trials show benefit if tested
at disease onset in human beings?" He concludes that the time has
come for new approaches to trial design: "The aim must be to design
informative, short, inexpensive, and sensitive phase I/II studies
before large phase III studies are attempted".
SOURCE: The Lancet Neurology
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