Minocycline to Treat Amyotrophic Lateral Sclerosis
- Conditions
- Amyotrophic Lateral Sclerosis
- Registration Number
- NCT00047723
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in function as detected by the ALS Functional Rating Scale (ALSFRS-R) in patients taking minocycline compared to those taking placebo.
- Secondary Outcome Measures
Name Time Method Changes in manual muscle testing (MMT), forced vital capacity (FVC, percent predicted), quality of life (QOL) and survival
Trial Locations
- Locations (29)
Drexel University College of Medicine, Hahnemann Campus
๐บ๐ธPhiladelphia, Pennsylvania, United States
University of Vermont
๐บ๐ธBurlington, Vermont, United States
Methodist Hospital
๐บ๐ธHouston, Texas, United States
Virginia Mason Medical Center
๐บ๐ธSeattle, Washington, United States
University of Kentucky
๐บ๐ธLexington, Kentucky, United States
University of California, Irvine
๐บ๐ธIrvine, California, United States
University of New Mexico
๐บ๐ธAlbuquerque, New Mexico, United States
University of Illinois
๐บ๐ธChicago, Illinois, United States
Indiana University School of Medicine
๐บ๐ธIndianapolis, Indiana, United States
Wake Forest University
๐บ๐ธWinston- Salem, North Carolina, United States
University of California Department of Neurology
๐บ๐ธLos Angeles, California, United States
Mayo Clinic
๐บ๐ธJacksonville, Florida, United States
University of Iowa
๐บ๐ธIowa City, Iowa, United States
Columbia Unversity, Eleanor and Lou Gehrig MDA/ALS Center
๐บ๐ธNew York, New York, United States
Metro Health Clinic
๐บ๐ธCleveland, Ohio, United States
UMDNJ/Robert Wood Johnson Medical Center
๐บ๐ธNew Brunswick, New Jersey, United States
University of Texas Southwestern
๐บ๐ธDallas, Texas, United States
University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
Carolinas Medical Center
๐บ๐ธCharlotte, North Carolina, United States
Washington University
๐บ๐ธSt. Louis, Missouri, United States
California Pacific Medical Center
๐บ๐ธSan Francisco, California, United States
Univ. of Colorado Health Sciences Center
๐บ๐ธDenver, Colorado, United States
Hennepin County Med Center
๐บ๐ธMinneapolis, Minnesota, United States
University of Minnesota
๐บ๐ธMinneapolis, Minnesota, United States
Duke University
๐บ๐ธDurham, North Carolina, United States
Oregon Health & Science University
๐บ๐ธPortland, Oregon, United States
University of Texas Health Sciences Center
๐บ๐ธSan Antonio, Texas, United States
University of Utah
๐บ๐ธSalt Lake City, Utah, United States
University of Kansas Medical Center
๐บ๐ธKansas City, Kansas, United States