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Home > "M" Clinical Trials Conditions > Minocycline to Treat Amyotrophic Lateral Sclerosis  Minocycline to Treat Amyotrophic Lateral Sclerosis
Minocycline to Treat Amyotrophic Lateral Sclerosis
For Condition: Amyotrophic Lateral Sclerosis
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 21 Years/85 Years
Genders: Both
Protocol Entry Criteria: To be eligible for enrollment in this study, subjects must meet the following eligibility criteria within fourteen days prior to randomization: Inclusion criteria: - A clinical diagnosis of laboratory-supported probable, probable or definite ALS, according to modified EL Escorial criteria. - FVC greater or equal to 75% of predicted. - Onset of weakness within 3 years prior to enrollment. - If patients are receiving riluzole they must be on a stable dose for at least the past thirty days. - Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test (adequate birth control includes use of intra-uterine device or oral contraceptives plus a barrier method, e.g. condom, diaphragm). - Willing and able to give signed informed consent that has been approved by your Institutional Review Board (IRB). Exclusion criteria: - Requirement for tracheotomy ventilation (or non-invasive ventilation > 23 hours/day). - Diagnosis of other neurodegenerative diseases (Parkinson's disease, Alzheimer's disease, etc). - FVC < 75% of predicted. - A clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days. - History of renal disease (screening creatinine greater than 1.5). - History of liver disease (screening alanine aminotransferase greater than 3 times the upper limit of normal). - History of hematologic disease (screening white blood cell count less than 3,800/mm3). - History of system lupus erythematosis (or screening ANA of 1:160 or greater). - Treatment with any medications that may cause lupus-like symptoms within 4 weeks of baseline visit (e.g. procainamide, hydralazine). - History of vestibular disease (excluding benign position vertigo). - Pregnancy or lactation. - Allergy to tetracycline antibiotics. - Use of minocycline within thirty days of enrollment (baseline visit). - Use of anti-epileptic medications other than gabapentin. - Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures. - History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols. - Use of any investigational drug within the past 30 days (Creatine, Vioxx, Celebrex, Topiramate). - Women with the potential to become pregnant who are not practicing effective birth control.
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
PaulGordon, Principal Investigator, Associate Medical Director, Eleanor and Lou Gehrig MDA/ALS Center, Columbia University Medical Center
University of California Department of Neurology *Recruiting*
Los Angeles, California,
United States
Recruiting Juliana Albu 310-825-3995
Metro Health Clinic *Recruiting*
Cleveland, Ohio,
United States
Recruiting Alice Liskay 216-778-5420
ALS Center at UCSF *Recruiting*
San Francisco, California,
United States
Recruiting Elizabeth Garwood 415-502-5064
University of Minnesota *Recruiting*
Minneapolis, Minnesota,
United States
Recruiting Susan Rolandelli 612-624-8431
Drexel University College of Medicine, Hahnemann Campus *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting Kellie Lind 215-762-5186
Univ. of Colorado Health Sciences Center *Recruiting*
Denver, Colorado,
United States
Recruiting Barbara Hammack 303-315-8720
Indiana University School of Medicine *Recruiting*
Indianapolis, Indiana,
United States
Recruiting Lisa Haas 317-630-8456
State University of New York Upstate Med Center *Recruiting*
Syracuse, New York,
United States
Recruiting Christine Lu 315-464-5004
University of Kansas Medical Center *Recruiting*
Kansas City, Kansas,
United States
Recruiting Allie Stuckey 913-588-0645
University of New Mexico *Recruiting*
Albuquerque, New Mexico,
United States
Recruiting Martha Meister 505-272-3342
Mayo Clinic *Recruiting*
Scottsdale, Arizona,
United States
Recruiting Joyce Wisbey 480-301-9392
University of Texas Southwestern *Recruiting*
Dallas, Texas,
United States
Recruiting Melinda Meacham 214-648-3329
Hennepin County Med Center *Recruiting*
Minneapolis, Minnesota,
United States
Recruiting Shirley Conn 612-341-7907
Wake Forest University *Recruiting*
Winston Salem, North Carolina,
United States
Recruiting Bonnie Dryman 336-716-2323
University of Vermont *Recruiting*
Burlington, Vermont,
United States
Recruiting Jessy Gardner 802-656-3876
Baylor College of Medicine *Recruiting*
Houston, Texas,
United States
Recruiting Joan Appel 713-798-3466
Washington University *Recruiting*
St. Louis, Missouri,
United States
Recruiting Charlie Harper-Wulf 314-362-6980
University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Mary Kelley 215-829-3053
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts,
United States
Recruiting Kristyn Newhall 617-726-0563
Rush Presbyterian University *Recruiting*
Chicago, Illinois,
United States
Recruiting Debbie Pierz 312-563-2208
Virginia Mason Medical Center *Recruiting*
Seattle, Washington,
United States
Recruiting Kate Franklin 206-223-6835
Oregon Health & Science University *Recruiting*
Portland, Oregon,
United States
Recruiting Kevin Blaine 503-494-4987
University of Kentucky *Recruiting*
Lexington, Kentucky,
United States
Recruiting Megan Thompson 859-233-4511
University of Texas Health Sciences Center *Recruiting*
San Antonio, Texas,
United States
Recruiting Pam Kittrell
University of Utah *Recruiting*
Salt Lake City, Utah,
United States
Recruiting Summer Davis 801-585-9055
California Pacific Medical Center *Recruiting*
San Francisco, California,
United States
Recruiting Jason Mass 415-600-3967
University of Iowa *Recruiting*
Iowa City, Iowa,
United States
Recruiting Cheri Doggett 319-356-8776
Columbia Unversity, Eleanor and Lou Gehrig MDA/ALS Center *Recruiting*
New York City, New York, 10032
United States
Recruiting Jackie Montes 212-305-3632
Carolinas Medical Center *Recruiting*
Charlotte, North Carolina,
United States
Recruiting Ruth King 704-355-8699
Additional Information:
Study ID Numbers: R01NS45294;
Study Start Date: January 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047723
Other Amyotrophic Lateral Sclerosis Studies:
1. Clinical trial of creatine in amyotrophic lateral sclerosis [ALS]
2. Safety testing of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Laughter & Crying)
3. Exogenous Toxicants and Genetic Susceptibility in ALS
4. Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
5. IGF-1/ALS Trial
Related Studies:
Other Amyotrophic Lateral Sclerosis Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Minocycline to Treat Amyotrophic Lateral Sclerosis
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