Expired Study
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Orange, California 92868


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

28.013


NCT ID:

NCT00790582


Secondary ID:


Study Acronym:

Lithium


Brief Title:

A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)


Official Title:

A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Forbes Norris MDA/ALS Research Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Robert G Miller, MD
Study Director
California Pacific Medical Center

Study Dates

Start Date:May 2008
Completion Date:July 2010
Completion Type:Anticipated
Primary Completion Date:March 2010
Primary Completion Type:Anticipated
Verification Date:March 2009
Last Changed Date:March 11, 2009
First Received Date:November 12, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:ALSFRS-R
Time Frame:Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Vital Capacity
Time Frame:Screen, Baseline, Month 1,3,6,9,12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety Labs
Time Frame:Screen, Baseline, Month 1,3,6,12
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Adverse Events
Time Frame:Month 1,3,6,9,12
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Lithium Level (blood)
Time Frame:Week 2, Month 1,6,12 and 2 weeks after a dose change
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:lithium carbonate
Description:The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
Arm Name:lithium carbonate

Study Arms

Study Arm Type:Experimental
Arm Name:lithium carbonate

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Forbes Norris MDA/ALS Research Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:Muscular Dystrophy Association

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:18250315

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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