Status:
COMPLETED
A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Forbes Norris MDA/ALS Research Center
Collaborating Sponsors:
Muscular Dystrophy Association
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
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 o...
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 ou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00790582
Start Date
May 1 2008
End Date
March 1 2010
Last Update
October 30 2020
Active Locations (10)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
UCLA Neuromuscular Research Center
Los Angeles, California, United States, 90095
3
UC Irvine MDA/ALS & Neuromuscular Center
Orange, California, United States, 92868
4
California Pacific Medical Center
San Francisco, California, United States, 94115