A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS) (Lithium)
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ClinicalTrials.gov Identifier: NCT00790582 |
Recruitment Status :
Completed
First Posted : November 13, 2008
Results First Posted : October 30, 2020
Last Update Posted : October 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Drug: lithium carbonate | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 109 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS) |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: lithium carbonate |
Drug: lithium carbonate
The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day. |
- Change in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised) [ Time Frame: Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13 ]This questionnaire has 12 questions about the patient's ability to complete certain daily activities. There are three questions each about the mouth area, arms, legs, and breathing. A normal score is 48 with each question scored at 0 (worst) to 4 (normal function). In research studies, the change in slope is measured in number of points changed per month. Maximum possible=48 (normal) Minimum=0 (severe dysfunction)
- Vital Capacity [ Time Frame: Screen, Baseline, Month 1,3,6,9,12 ]Vital Capacity (VC) is a breathing test in which the patient is asked to take a deep breath and then blow out all of the breath through a tube. The volume is measured in number of liters. It is converted to a percent predicted for the patient's age, height, and gender.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790582
United States, Arizona | |
Mayo Clinic | |
Scottsdale, Arizona, United States, 85259 | |
United States, California | |
UCLA Neuromuscular Research Center | |
Los Angeles, California, United States, 90095 | |
UC Irvine MDA/ALS & Neuromuscular Center | |
Orange, California, United States, 92868 | |
California Pacific Medical Center | |
San Francisco, California, United States, 94115 | |
United States, Kansas | |
Kansas University Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Missouri | |
Washington University Department of Neurology | |
Saint Louis, Missouri, United States, 63110 | |
United States, Oregon | |
Providence ALS Clinic | |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
University of Pennsylvania Neurological Institute | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Methodist Neurological Institute | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
University of Utah Clinical Neurosciences Center | |
Salt Lake City, Utah, United States, 84132 |
Study Director: | Robert G Miller, MD | California Pacific Medical Center |
Responsible Party: | Dr. Robert Miller, Director, Forbes Norris MDA/ALS Research Center |
ClinicalTrials.gov Identifier: | NCT00790582 |
Other Study ID Numbers: |
28.013 |
First Posted: | November 13, 2008 Key Record Dates |
Results First Posted: | October 30, 2020 |
Last Update Posted: | October 30, 2020 |
Last Verified: | October 2020 |
ALS Amyotrophic Lateral Sclerosis Lou Gehrig's Disease Lithium Lithium Carbonate |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies |
Metabolic Diseases Lithium Carbonate Antidepressive Agents Psychotropic Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |