Minocycline to Treat Amyotrophic Lateral Sclerosis

Completed · Phase 3

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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).

Key facts

Study ID

NCT00047723

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

400

Starts

2003-01-01

Expected to finish

2007-01-01

Last updated by the study team

2007-12-21

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• 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, 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, United States
• Drexel University College of Medicine, Hahnemann Campus — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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