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.|
|ClinicalTrials.gov Identifier: NCT00790582|
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : October 30, 2020
Last Update Posted : October 30, 2020
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
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|
|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|