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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forbes Norris MDA/ALS Research Center
• Collaborator: Muscular Dystrophy Association
• Treatments: Lithium Carbonate

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