DISEASE CLASSIFICATION(S):
Amyotrophic Lateral Sclerosis(ALS)
NAME OF CLINICAL TRIAL/STUDY:
Lithium Open-Label Study
TRIAL RESULTS:
April 2010
At the April 2010 meeting of the American Academy of Neurology, results for this trial were announced. Lithium did not slow the progress of the disease. Side effects were numerous, and some were serious.
See MDA Study Shows Lithium Not Helpful in ALS.TRIAL UPDATES:
September 2009
A study of lithium in ALS being supported by the National Institutes of Health, the ALS Association and Health Canada, ended this month. Its investigators announced on Sept. 23, 2009, that an interim analysis had failed to find the study drug beneficial.
(See Lithium and Riluzole in ALS.)
The investigators on the MDA-supported study, below, say their study design is different, and at this time, no decision has been made to stop this study.
February 2009
This MDA-supported lithium in ALS trial has completed its enrollment and is closed to further recruitment.
For safety reasons, the highest dosagelevel used in the trial was 450 milligrams per day. The safety of this drug in people with ALS is still unclear, and the investigators are gathering data on side effects.
Lithium interacts with many other drugs, and the investigators have recommended that it not be used in ALS outside a careful study.
Safety and efficacy of lithium in ALS will be assessed after trial participants have been on the drug for one year. In the meantime, many ALS patients taking lithium have documented their responses at Research: Lithium & ALS on the Patients Like Me Web site . No dramatic effects have been seen so far.
PURPOSE AND RATIONALE:
The purpose of this study is to find out whether lithium carbonate is safe for use in people with amyotrophic lateral sclerosis (ALS) and if it has any potential to slow the progression of the disease. The study is being conducted after a small pilot study in Italy showed very promising results.
STUDY DETAILS:
There are 10 centers that are participating in this trial around the United States. Participants will be required to go to their local study site for visits seven times in one year and will have four telephone interviews during that time. There will be a variety of questionnaires, blood draws and a breathing test at each visit.
Details on each study site will be posted as they become available, and prospective participants are encouraged to contact the nearest site.
The investigators expect there will be a great deal of enthusiasm for this trial and that it will fill within one to two months. The study will last for a year. Results should be available three to four months after the last patient finishes his or her year.
Patients will not be paid or reimbursed for expenses during this trial.
OPENING DATES:
June 2008
CLOSING DATES:
1/2009
TARGET NUMBER OF PARTICIPANTS:
100
RECRUITMENT STATUS:
Closed
ELIGIBILITY REQUIREMENTS:
Participants must:
- have a diagnosis of ALS, which has been confirmed at the local study site
- have had onset of weakness within the last three years
- have a breathing (FVC) test score of 75 percent of normal or better
- be in good general health
- meet other requirements to be discussed at the study site
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. Epub 2008 Feb 4. PubMed abstract.
