A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Lithium
1 other identifier
interventional
109
1 country
10
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 of the disease. Since there is no placebo in this study, all patients will be taking lithium carbonate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2008
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
October 30, 2020
CompletedOctober 30, 2020
October 1, 2020
1.8 years
November 12, 2008
February 3, 2011
October 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised)
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)
Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13
Secondary Outcomes (1)
Vital Capacity
Screen, Baseline, Month 1,3,6,9,12
Study Arms (1)
lithium carbonate
EXPERIMENTALInterventions
The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
UCLA Neuromuscular Research Center
Los Angeles, California, 90095, United States
UC Irvine MDA/ALS & Neuromuscular Center
Orange, California, 92868, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Washington University Department of Neurology
St Louis, Missouri, 63110, United States
Providence ALS Clinic
Portland, Oregon, 97213, United States
University of Pennsylvania Neurological Institute
Philadelphia, Pennsylvania, 19107, United States
Methodist Neurological Institute
Houston, Texas, 77030, United States
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, 84132, United States
Related Publications (1)
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.
PMID: 18250315BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Giovanna Kushner
- Organization
- Forbes Norris MDA/ALS Center
Study Officials
- STUDY DIRECTOR
Robert G Miller, MD
California Pacific Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 12, 2008
First Posted
November 13, 2008
Study Start
May 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
October 30, 2020
Results First Posted
October 30, 2020
Record last verified: 2020-10