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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Forbes Norris MDA/ALS Research Center.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by:
Forbes Norris MDA/ALS Research Center
ClinicalTrials.gov Identifier:
NCT00790582
First received: November 12, 2008
Last updated: March 11, 2009
Last verified: March 2009

November 12, 2008
March 11, 2009
May 2008
March 2010   (Final data collection date for primary outcome measure)
ALSFRS-R [ Time Frame: Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13 ]
Same as current
Complete list of historical versions of study NCT00790582 on ClinicalTrials.gov Archive Site
  • Vital Capacity [ Time Frame: Screen, Baseline, Month 1,3,6,9,12 ]
  • Safety Labs [ Time Frame: Screen, Baseline, Month 1,3,6,12 ]
  • Adverse Events [ Time Frame: Month 1,3,6,9,12 ]
  • Lithium Level (blood) [ Time Frame: Week 2, Month 1,6,12 and 2 weeks after a dose change ]
Same as current
Not Provided
Not Provided
 
A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
Drug: lithium carbonate
The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
Experimental: lithium carbonate
Intervention: Drug: lithium carbonate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
July 2010
March 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00790582
28.013
Yes
Not Provided
Not Provided
Not Provided
Robert G. Miller MD / Director, Forbes Norris MDA/ALS Research Center at California Pacific Medical Center
Forbes Norris MDA/ALS Research Center
Muscular Dystrophy Association
Study Director: Robert G Miller, MD California Pacific Medical Center
Forbes Norris MDA/ALS Research Center
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP