A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT00790582
Last Updated: 2020-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2008-05-31
2010-03-31
Brief Summary
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Detailed Description
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A recent article was published in a highly regarded medical journal that showed a positive effect of lithium carbonate on an ALS type mouse. The researchers then studied a very small number of people with ALS, giving 16 people lithium carbonate with riluzole and giving 28 people only riluzole. The people who took lithium remained stronger for a considerably longer period of time. However, the study was very small and we cannot really tell if lithium works unless a larger study is performed. It is not well understood why lithium carbonate might be helpful but it is believed that it may play a role in protecting the motor nerves from the damage of ALS.
If you choose to participate, you will need to go to your study clinic for research study visits 7 times in one year and you will have 4 telephone interviews during that time. These visits and phone calls could take up to 17 hours in total.
Caution: Lithium is an FDA approved drug used for some psychiatric disorders. It is not FDA approved for ALS. Lithium has many potentially serious side effects and must only be taken under close supervision of your physician.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lithium carbonate
lithium carbonate
The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
Interventions
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lithium carbonate
The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
21 Years
80 Years
ALL
No
Sponsors
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Muscular Dystrophy Association
OTHER
Forbes Norris MDA/ALS Research Center
OTHER
Responsible Party
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Dr. Robert Miller
Director
Principal Investigators
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Robert G Miller, MD
Role: STUDY_DIRECTOR
California Pacific Medical Center
Locations
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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
Countries
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References
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Fornai F, Longone P, Cafaro L, Kastsiuchenka O, Ferrucci M, Manca ML, Lazzeri G, Spalloni A, Bellio N, Lenzi P, Modugno N, Siciliano G, Isidoro C, Murri L, Ruggieri S, Paparelli A. Lithium delays progression of amyotrophic lateral sclerosis. Proc Natl Acad Sci U S A. 2008 Feb 12;105(6):2052-7. doi: 10.1073/pnas.0708022105. Epub 2008 Feb 4.
Other Identifiers
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28.013
Identifier Type: -
Identifier Source: org_study_id