Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The objective of this study is to compare two combinations of drugs, minocycline and creatine or celecoxib and creatine, in a phase II trial designed to determine which combination is more effective for ALS.

Key facts

Study ID

NCT00355576

Run by

Columbia University

People needed

86

Starts

2006-07-01

Expected to finish

2007-05-01

Last updated by the study team

2011-02-01

Who can join

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

You may qualify if…

• A clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS, according to modified EL Escorial criteria
• FVC greater or equal to 60% at the screening visit
• Symptom onset within 5 years
• 21 to 85 years of age
• If patients are taking riluzole, they must be on a stable dose for at least the past thirty days
• A woman of childbearing age, must be nonlactating and surgically sterile or using an effective method of birth control (barrier method) and have a negative pregnancy test
• Able to maintain adequate hydration levels defined as 6-8 cups (8ounces/cup) of water or a non-caffeinated beverage per day
• Willing and able to give signed informed consent that has been approved by an Institutional Review Board (IRB)

You may not qualify if…

• Tracheotomy and mechanical ventilation
• Diagnosis of other neurodegenerative diseases (Parkinson's disease, Alzheimer's disease, etc)
• Unstable medical illness (coronary artery disease, advanced cancer, active esophageal or gastroduodenal ulcers, etc) in the last one year
• Systemic Lupus Erythematosis
• FVC < 60%
• Pregnancy or lactation
• Allergy to minocycline, tetracyclines, celecoxib, sulfonamides, NSAIDS, or creatine
• History of congestive heart failure
• Renal disease [baseline Cr > 1.5 (men) or 1.2 (women)]
• History of significant hepatic disease (baseline AST/ALT or bilirubin > 1.5x normal)
• Use of an investigational agent within thirty days of enrollment
• First degree relative with ALS or gene identified familial ALS
• Inability or unwillingness to maintain adequate daily hydration (defined above)
• Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
• History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.

Where it is running

• Phoenix Neurological Associates — Phoenix, Arizona, United States
• UCLA — Los Angeles, California, United States
• University of California Irvine — Orange, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• University of Illinois — Chicago, Illinois, United States
• University of Kansas — Kansas City, Kansas, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• UMDNJ — New Brunswick, New Jersey, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Beth Israel — New York, New York, United States
• Columbia University — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.