A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease. Since there is no placebo in this study, all patients will be taking lithium carbonate.

Key facts

Study ID

NCT00790582

Run by

Forbes Norris MDA/ALS Research Center

People needed

109

Starts

2008-05-01

Expected to finish

2010-03-01

Last updated by the study team

2020-10-30

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of laboratory-supported probable, probable, or definite ALS
• Vital capacity of at least 75% of predicted
• Onset of weakness within 3 years prior to enrollment
• If patients are on riluzole, they must be on a stable dose for at least 30 days prior to baseline visit
• Women of childbearing potential must be surgically sterile or using an effective method of birth control and have a negative pregnancy test
• Willing and able to give informed consent

You may not qualify if…

• Diagnosis of other neurodegenerative disease
• Need tracheotomy ventilation or non-invasive ventilation 23 or more hours/day
• Clinically significant history of any unstable medical condition in past 30 days
• History of renal
• History of liver disease
• Current pregnancy or lactation
• Use of lithium within thirty days of enrollment
• Significantly limited mental capacity
• History of recent drug or alcohol abuse
• Use of any investigational drug within 30 days prior to enrollment

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• UCLA Neuromuscular Research Center — Los Angeles, California, United States
• UC Irvine MDA/ALS & Neuromuscular Center — Orange, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Washington University Department of Neurology — St Louis, Missouri, United States
• Providence ALS Clinic — Portland, Oregon, United States
• University of Pennsylvania Neurological Institute — Philadelphia, Pennsylvania, United States
• Methodist Neurological Institute — Houston, Texas, United States
• University of Utah Clinical Neurosciences Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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