DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Forbes Norris MDA/ALS Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amyotrophic Lateral Sclerosis

Intervention: lithium carbonate (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Forbes Norris MDA/ALS Research Center

Official(s) and/or principal investigator(s):
Robert G Miller, MD, Study Director, Affiliation: California Pacific Medical Center

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: ALSFRS-R

Secondary outcome:

Vital Capacity

Safety Labs

Adverse Events

Lithium Level (blood)

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.

Eligibility

Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Related 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.

Starting date: May 2008
Last updated: March 11, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017