Minocycline to Treat Amyotrophic Lateral Sclerosis
1 other identifier
interventional
400
1 country
30
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2003
Typical duration for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2002
CompletedFirst Posted
Study publicly available on registry
October 17, 2002
CompletedStudy Start
First participant enrolled
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedDecember 21, 2007
December 1, 2007
October 16, 2002
December 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in function as detected by the ALS Functional Rating Scale (ALSFRS-R) in patients taking minocycline compared to those taking placebo.
Secondary Outcomes (1)
Changes in manual muscle testing (MMT), forced vital capacity (FVC, percent predicted), quality of life (QOL) and survival
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Mayo Clinic
Scottsdale, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of California Department of Neurology
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Univ. of Colorado Health Sciences Center
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Illinois
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Hennepin County Med Center
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
UMDNJ/Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Columbia Unversity, Eleanor and Lou Gehrig MDA/ALS Center
New York, New York, 10032, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Metro Health Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Drexel University College of Medicine, Hahnemann Campus
Philadelphia, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
Methodist Hospital
Houston, Texas, United States
University of Texas Health Sciences Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Related Publications (1)
Gordon PH, Moore DH, Miller RG, Florence JM, Verheijde JL, Doorish C, Hilton JF, Spitalny GM, MacArthur RB, Mitsumoto H, Neville HE, Boylan K, Mozaffar T, Belsh JM, Ravits J, Bedlack RS, Graves MC, McCluskey LF, Barohn RJ, Tandan R; Western ALS Study Group. Efficacy of minocycline in patients with amyotrophic lateral sclerosis: a phase III randomised trial. Lancet Neurol. 2007 Dec;6(12):1045-53. doi: 10.1016/S1474-4422(07)70270-3. Epub 2007 Nov 5.
PMID: 17980667RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul H. Gordon, M.D.,
Associate Medical Director, Eleanor and Lou Gehrig MDA/ALS Center, Columbia University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 16, 2002
First Posted
October 17, 2002
Study Start
January 1, 2003
Study Completion
January 1, 2007
Last Updated
December 21, 2007
Record last verified: 2007-12