-- NIH funded clinical trial - ALS with antibiotics

From: zipzip (mcpucho_at_hotmail.com)
Date: 03/02/05 

Date: 1 Mar 2005 17:56:45 -0800

http://www.clinicaltrials.gov/ct/gui/show/NCT00047723?order=2

This study is currently recruiting patients.

Purpose -

The purpose of this trial is to test the safety, tolerability, and
effectiveness of minocycline compared to placebo in patients with
amyotrophic lateral sclerosis (ALS).

Amyotrophic Lateral Sclerosis
Drug: minocycline
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Further Study Details:

Expected Total Enrollment: 400

Study start: January 2003

ALS is a progressive neurodegenerative disorder without cure or known
treatment that significantly improves function. Loss of motor neurons
in the brain and spinal cord of ALS patients causes the progressive
symptoms. Laboratory studies have linked inducible nitric oxide
synthase (iNOS) and caspase enzyme activation to motor nerve cell death
in ALS. Minocycline-a medication currently approved by the FDA for
treatment of bacterial infections-is a tetracycline antibiotic with
high central nervous system penetration when taken orally. The drug
inhibits the activity of iNOS and caspase enzymes.

Minocycline has been tested and shown to protect nerve cells in many
scientific experiments. It reduces cell death and prolongs survival in
animal models of ALS, stroke, trauma, Huntington's disease, and
Parkinson's disease. It has been shown to be beneficial in many
different animal experiments of ALS, conducted in Europe, Canada and
the United States.

Minocycline has been tested in 2 preliminary human trials and has been
shown to be safe in patients with ALS. It has been well tolerated in
conjunction with riluzole (Rilutek), the only currently FDA-approved
medication for ALS.

This trial is the final important step in determining whether
minocycline improves the course of ALS. The principle objective of
this clinical trial is to determine whether minocycline slows disease
progression and helps maintain function in patients with ALS. This
multi-center placebo-controlled study will select patients early in the
course of ALS, when a neuroprotective therapy may be most beneficial.
The study will measure change in function (as detected by ALSFRS-R
scores), strength, pulmonary function, survival, and quality of life.
Participants will undergo monthly outpatient evaluations and analysis
of laboratory and adverse events. This is a 13-month study.

Relevant Pages

  • Minocycline Has Harmful Effect on Patients With Motor Neuron Disease
    ... Minocycline Has Harmful Effect on Patients With Motor Neuron Disease ... motor neuron loss in transgenic mouse models of ALS. ...
    (alt.support.mult-sclerosis)
  • 1999: Treatment of early seropositive rheumatoid arthritis with minocycline
    ... Treatment of early seropositive rheumatoid arthritis with minocycline: ... This study was undertaken to compare patients ... treated with conventional therapy in the early phase of their RA and ... versus placebo. ...
    (sci.med.diseases.lyme)
  • Is it possible for Lyme disease to be misdiagnosed as ALS?
    ... Is it possible for Lyme disease to be misdiagnosed as ALS? ... percentage of the ALS patients were seropositive for Lyme Disease. ... trial underway sponsored by the NIH in which an antibiotic, Minocycline, is ...
    (sci.med.diseases.lyme)
  • LD and ALS
    ... Is it possible for Lyme disease to be misdiagnosed as ALS? ... percentage of the ALS patients were seropositive for Lyme Disease. ... trial underway sponsored by the NIH in which an antibiotic, Minocycline, is ...
    (sci.med.diseases.lyme)
  • It is possible for Lyme to be misdiagnosed as ALS?
    ... Is it possible for Lyme disease to be misdiagnosed as ALS? ... percentage of the ALS patients were seropositive for Lyme Disease. ... trial underway sponsored by the NIH in which an antibiotic, Minocycline, is ...
    (sci.med.diseases.lyme)