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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790582
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by (Responsible Party):
Dr. Robert Miller, Forbes Norris MDA/ALS Research Center

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 13, 2008
Results First Submitted Date  ICMJE February 3, 2011
Results First Posted Date  ICMJE October 30, 2020
Last Update Posted Date October 30, 2020
Study Start Date  ICMJE May 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2020)
Change in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised) [ Time Frame: Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13 ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
ALSFRS-R [ Time Frame: Baseline, Month 1,3,4.5,6,7.5,9,10.5,12,13 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2020)
Vital Capacity [ Time Frame: Screen, Baseline, Month 1,3,6,9,12 ]
Vital Capacity (VC) is a breathing test in which the patient is asked to take a deep breath and then blow out all of the breath through a tube. The volume is measured in number of liters. It is converted to a percent predicted for the patient's age, height, and gender.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Drug: lithium carbonate
The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
Study Arms  ICMJE Experimental: lithium carbonate
Intervention: Drug: lithium carbonate
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. 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2020)
109
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2008)
100
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00790582
Other Study ID Numbers  ICMJE 28.013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Robert Miller, Forbes Norris MDA/ALS Research Center
Study Sponsor  ICMJE Forbes Norris MDA/ALS Research Center
Collaborators  ICMJE Muscular Dystrophy Association
Investigators  ICMJE
Study Director: Robert G Miller, MD California Pacific Medical Center
PRS Account Forbes Norris MDA/ALS Research Center
Verification Date October 2020

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