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Trial record 1 of 4 for:    lithium and als
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A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS) (Lithium)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00790582
Recruitment Status : Unknown
Verified March 2009 by Forbes Norris MDA/ALS Research Center.
Recruitment status was:  Active, not recruiting
First Posted : November 13, 2008
Last Update Posted : March 12, 2009
Muscular Dystrophy Association
Information provided by:
Forbes Norris MDA/ALS Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: lithium carbonate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : July 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.

Primary Outcome Measures :
  1. ALSFRS-R [ Time Frame: Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13 ]

Secondary Outcome Measures :
  1. Vital Capacity [ Time Frame: Screen, Baseline, Month 1,3,6,9,12 ]
  2. Safety Labs [ Time Frame: Screen, Baseline, Month 1,3,6,12 ]
  3. Adverse Events [ Time Frame: Month 1,3,6,9,12 ]
  4. Lithium Level (blood) [ Time Frame: Week 2, Month 1,6,12 and 2 weeks after a dose change ]

Information from the National Library of Medicine

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.

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00790582

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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
St. 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
Sponsors and Collaborators
Forbes Norris MDA/ALS Research Center
Muscular Dystrophy Association
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Study Director: Robert G Miller, MD California Pacific Medical Center
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Responsible Party: Robert G. Miller MD / Director, Forbes Norris MDA/ALS Research Center at California Pacific Medical Center Identifier: NCT00790582    
Other Study ID Numbers: 28.013
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009
Keywords provided by Forbes Norris MDA/ALS Research Center:
Amyotrophic Lateral Sclerosis
Lou Gehrig's Disease
Lithium Carbonate
Additional relevant MeSH terms:
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Amyotrophic Lateral Sclerosis
Lithium Carbonate
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs