A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Information source: Forbes Norris MDA/ALS Research Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amyotrophic Lateral Sclerosis
Intervention: lithium carbonate (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Forbes Norris MDA/ALS Research Center Official(s) and/or principal investigator(s): Robert G Miller, MD, Study Director, Affiliation: California Pacific Medical Center
Summary
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.
Clinical Details
Official title: A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: ALSFRS-R
Secondary outcome: Vital CapacitySafety Labs Adverse Events Lithium Level (blood)
Detailed description:
This is a Phase II Screening study. There is no placebo (inactive or 'fake' drug) in this
study, meaning that all participants will be taking lithium carbonate. 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.
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Mayo Clinic, Scottsdale, Arizona 85259, United States
UCLA Neuromuscular Research Center, Los Angeles, California 90095, United States
UC Irvine MDA/ALS & Neuromuscular Center, Orange, California 92868, United States
California Pacific Medical Center, San Francisco, California 94115, United States
Kansas University Medical Center, Kansas City, Kansas 66160, United States
Washington University Department of Neurology, St. Louis, Missouri 63110, United States
Providence ALS Clinic, Portland, Oregon 97213, United States
University of Pennsylvania Neurological Institute, Philadelphia, Pennsylvania 19107, United States
Methodist Neurological Institute, Houston, Texas 77030, United States
University of Utah Clinical Neurosciences Center, Salt Lake City, Utah 84132, United States
Additional Information
Related publications: 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. Erratum in: Proc Natl Acad Sci U S A. 2008 Oct 21;105(42):16404-7.
Starting date: May 2008
Last updated: March 11, 2009
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